BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE HAD COMPATIBILITY PROBLEM WITH THE XTREM CONNECTION CABLE. THE PROBLEM WAS THAT THE YELLOW CONNECTORS FOUND IN BD TRAINING LEADS NO LONGER FIT ON XTREM STEERABLE LEAD CABLES. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 21MAR2025, IT WAS REPORTED THAT THE PATIENT HAS SUFFERED HARM AND WAS NOT THE ONLY ONE. THE PROBLEM HAD PERSISTED SINCE LAST YEAR. A REPORT HAD ALREADY BEEN MADE TO THE PHARMACY DEPARTMENT AND HAD REMOVED THE DEFECTIVE YELLOW CONNECTORS FROM OUR SERVICE SO THAT IT WOULD NO LONGER HAVE THIS PROBLEM. THE PREJUDICE WAS THAT IN THE EVENT OF AN EMERGENCY NEED FOR CARDIAC STIMULATION, THE CURRENT ASSEMBLY WITH DEFECTIVE YELLOW CONNECTORS DID NOT ALLOW THE STIMULATION TO BE DELIVERED. AS POINTED OUT TO IN A PREVIOUS EMAIL, THE CUSTOMER CANNOT PROVIDE WITH A BATCH NUMBER, BECAUSE THESE ELECTRODES WERE REUSED SEVERAL TIMES. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 27MAR2025, STATED THAT THE CUSTOMER CANNOT PROVIDE YOU WITH A BATCH NUMBER, AS THESE ELECTRODES ARE REUSED SEVERAL TIMES AND THESE ARE MATERIALS THAT HAVE NOT BEEN SOILED, AND THIS MATERIAL HAS ALREADY BEEN USED AT LEAST ONCE. THE SAMPLES ARE NOT CONTAMINATED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 28MAR2025, IT WAS REPORTED THAT AT THE TIME OF THE INCIDENT, THE PATIENT DID NOT SUFFER ANY PHYSICAL INJURY, BUT HIS TREATMENT TOOK LONGER. HE HAD A FEW SECONDS WITHOUT A CARDIAC STIMULUS (THE TIME IT TOOK TO FIND OTHER ELECTRODES KEPT IN THE ROOM AND CHANGE THEM). THE EVENT THAT TRIGGERED THIS REPORT OCCURRED ON (B)(6) 2025. BUT SEVERAL EVENTS HAVE OCCURRED AND EACH TIME IT WAS THE SAME PROBLEM AND THE SAME SOLUTION (DEFECTIVE ELECTRODES ARE DISCARDED AND OTHERS ARE USED TO REPLACE THEM).

Additional Manufacturer Narrative

THE REPORTED EVENT WAS CONFIRMED CAUSE UNKNOWN. REVIEW OF THE CATHETER AND ASSOCIATED COMPONENTS INDICATED THE COMPLAINT IS CONFIRMED. UPON REVIEW, IT WAS NOTED THAT THE YELLOW CONNECTORS HAD A ¿LOOSE FIT¿. BASED ON THE INFORMATION PROVIDED ABOUT THE RE-USE OF COMPONENTS AND FROM THE EVALUATION ACTIVITIES DETAILED ABOVE, THE CAUSE OF THE EVENT COULD NOT BE GAUGED. A DHR WAS REQUESTED BUT CANNOT BE PERFORMED AT THIS TIME AS THE LOT NUMBER IS UNKNOWN. THE LABELING IS FOUND TO BE ADEQUATE. CORRECTION: E UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE HAD COMPATIBILITY PROBLEM WITH THE XTREM CONNECTION CABLE. THE PROBLEM WAS THAT THE YELLOW CONNECTORS FOUND IN BD TRAINING LEADS NO LONGER FIT ON XTREM STEERABLE LEAD CABLES. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 21MAR2025, IT WAS REPORTED THAT THE PATIENT HAS SUFFERED HARM AND WAS NOT THE ONLY ONE. THE PROBLEM HAD PERSISTED SINCE LAST YEAR. A REPORT HAD ALREADY BEEN MADE TO THE PHARMACY DEPARTMENT AND HAD REMOVED THE DEFECTIVE YELLOW CONNECTORS FROM OUR SERVICE SO THAT IT WOULD NO LONGER HAVE THIS PROBLEM. THE PREJUDICE WAS THAT IN THE EVENT OF AN EMERGENCY NEED FOR CARDIAC STIMULATION, THE CURRENT ASSEMBLY WITH DEFECTIVE YELLOW CONNECTORS DID NOT ALLOW THE STIMULATION TO BE DELIVERED. AS POINTED OUT TO IN A PREVIOUS EMAIL, THE CUSTOMER CANNOT PROVIDE WITH A BATCH NUMBER, BECAUSE THESE ELECTRODES WERE REUSED SEVERAL TIMES. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 27MAR2025, STATED THAT THE CUSTOMER CANNOT PROVIDE YOU WITH A BATCH NUMBER, AS THESE ELECTRODES ARE REUSED SEVERAL TIMES AND THESE ARE MATERIALS THAT HAVE NOT BEEN SOILED, AND THIS MATERIAL HAS ALREADY BEEN USED AT LEAST ONCE. THE SAMPLES ARE NOT CONTAMINATED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 28MAR2025, IT WAS REPORTED THAT AT THE TIME OF THE INCIDENT, THE PATIENT DID NOT SUFFER ANY PHYSICAL INJURY, BUT HIS TREATMENT TOOK LONGER. HE HAD A FEW SECONDS WITHOUT A CARDIAC STIMULUS (THE TIME IT TOOK TO FIND OTHER ELECTRODES KEPT IN THE ROOM AND CHANGE THEM). THE EVENT THAT TRIGGERED THIS REPORT OCCURRED ON 18/03/2025. BUT SEVERAL EVENTS HAVE OCCURRED AND EACH TIME IT WAS THE SAME PROBLEM AND THE SAME SOLUTION (DEFECTIVE ELECTRODES ARE DISCARDED AND OTHERS ARE USED TO REPLACE THEM).

Description of Event or Problem

IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE HAD COMPATIBILITY PROBLEM WITH THE XTREM CONNECTION CABLE. THE PROBLEM WAS THAT THE YELLOW CONNECTORS FOUND IN BD TRAINING LEADS NO LONGER FIT ON XTREM STEERABLE LEAD CABLES. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 21MAR2025, IT WAS REPORTED THAT THE PATIENT HAS SUFFERED HARM AND WAS NOT THE ONLY ONE. THE PROBLEM HAD PERSISTED SINCE LAST YEAR. A REPORT HAD ALREADY BEEN MADE TO THE PHARMACY DEPARTMENT AND HAD REMOVED THE DEFECTIVE YELLOW CONNECTORS FROM OUR SERVICE SO THAT IT WOULD NO LONGER HAVE THIS PROBLEM. THE PREJUDICE WAS THAT IN THE EVENT OF AN EMERGENCY NEED FOR CARDIAC STIMULATION, THE CURRENT ASSEMBLY WITH DEFECTIVE YELLOW CONNECTORS DID NOT ALLOW THE STIMULATION TO BE DELIVERED. AS POINTED OUT TO IN A PREVIOUS EMAIL, THE CUSTOMER CANNOT PROVIDE WITH A BATCH NUMBER, BECAUSE THESE ELECTRODES WERE REUSED SEVERAL TIMES. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 27MAR2025, STATED THAT THE CUSTOMER CANNOT PROVIDE YOU WITH A BATCH NUMBER, AS THESE ELECTRODES ARE REUSED SEVERAL TIMES AND THESE ARE MATERIALS THAT HAVE NOT BEEN SOILED, AND THIS MATERIAL HAS ALREADY BEEN USED AT LEAST ONCE. THE SAMPLES ARE NOT CONTAMINATED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 28MAR2025, IT WAS REPORTED THAT AT THE TIME OF THE INCIDENT, THE PATIENT DID NOT SUFFER ANY PHYSICAL INJURY, BUT HIS TREATMENT TOOK LONGER. HE HAD A FEW SECONDS WITHOUT A CARDIAC STIMULUS (THE TIME IT TOOK TO FIND OTHER ELECTRODES KEPT IN THE ROOM AND CHANGE THEM). THE EVENT THAT TRIGGERED THIS REPORT OCCURRED ON (B)(6) 2025. BUT SEVERAL EVENTS HAVE OCCURRED AND EACH TIME IT WAS THE SAME PROBLEM AND THE SAME SOLUTION (DEFECTIVE ELECTRODES ARE DISCARDED AND OTHERS ARE USED TO REPLACE THEM).

Additional Manufacturer Narrative

THE REPORTED EVENT WAS CONFIRMED CAUSE UNKNOWN. SAMPLE EVALUATION RESULTS: THE INVESTIGATORS CHECKED THE ¿FIT¿ OF BOTH THE Y-ADAPTERS BY ATTACHING THE ADAPTERS TO THE PROXIMAL AND DISTAL TAIL, RESPECTIVELY, OF A SAMPLE UNIT, SINCE THE PROXIMAL TAIL AND DISTAL SAFETY TAIL ASSOCIATED WITH THE COMPLAINT SAMPLE WERE NOT RETURNED. IT WAS OBSERVED THAT WHEN BOTH Y-ADAPTERS WERE ATTACHED TO THE TAIL, THE INVESTIGATORS NOTED THAT ALTHOUGH IT WAS A LOOSE FIT, THE ADAPTERS DID NOT FALL OFF THE TAIL. SAMPLE EVALUATION CONCLUSIONS: REVIEW OF THE CATHETER AND ASSOCIATED COMPONENTS INDICATED THE COMPLAINT IS CONFIRMED, AS THE INVESTIGATORS NOTED A ¿LOOSE¿ FIT WHEN THE SAFETY ADAPTERS ASSOCIATED WITH THE COMPLAINT SAMPLE WERE ATTACHED TO THE DISTAL TAIL OF A SAMPLE 520007P UNIT. REVIEW OF THE IQC PACKETS CONFIRMED THAT THE COMPONENTS USED TO PRODUCE THE ¿POTENTIAL¿ LOT IN SCOPE OF THIS INVESTIGATION MEET SPECIFICATION REQUIREMENTS AND FROM THE EVALUATION ACTIVITIES, THE COMPLAINT COULD NOT BE ATTRIBUTED TO MANUFACTURING. ROOT CAUSE SUMMARY: THE PROBLEM WAS THAT THE YELLOW CONNECTORS HAD A ¿LOOSE FIT¿. THERE ARE POTENTIAL RELATED ROOT CAUSES FOR THE NOTED DEFECT: AS STATED THE CUSTOMER COULD NOT PROVIDE A BATCH NUMBER. IT WAS NOTED THAT THESE ELECTRODES HAVE BEEN REUSED SEVERAL TIMES AND THE MATERIAL TO HAVE BEEN ALREADY USED AT LEAST ONCE. THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATES THE FOLLOWING: CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS. DESCRIPTION BARD TEMPORARY PACING CATHETERS ARE CONSTRUCTED OF A WOVEN OR EXTRUDED POLYURETHANE SHAFT WITH PLATINUM OR STAINLESS STEEL ELECTRODES. CERTAIN CATHETERS MAY INCORPORATE ONE OR MORE LUMENS FOR FLUID INFUSION, PRESSURE MONITORING, BLOOD SAMPLING, OR BALLOON INFLATION. THE BALLOONS ARE MANUFACTURED USING LATEX MATERIAL. SOME PRODUCT MAY BE PACKAGED WITH ACCESSORIES SUCH AS A NEEDLE CANNULA, SAFETY LEAD ADAPTER, AN ECG ADAPTER, OR A BALLOON INFLATION SYRINGE. INDICATIONS FOR USE BARD TEMPORARY PACING CATHETERS ARE DESIGNED TO TRANSMIT AN ELECTRICAL SIGNAL FROM AN EXTERNAL PULSE GENERATOR TO THE HEART OR FROM THE HEART TO A MONITORING DEVICE. WHEN AN INTERNAL LUMEN IS PRESENT (OTHER THAN THE ONE USED FOR BALLOON INFLATION), IT MAY BE USED FOR FLUID INFUSION, PRESSURE MONITORING, OR BLOOD SAMPLING. WARNINGS: GENERAL WARNINGS THESE WARNINGS APPLY TO ALL BARD® TEMPORARY PACING ELECTRODE CATHETERS. INAPPROPRIATE ELECTRICAL CONNECTIONS, E.G. INTO A WALL SOCKET, MAY POSE SERIOUS RISK OF ADVERSE HEALTH CONSEQUENCES OR DEATH. PLEASE ENSURE THAT THE CATHETER IS CONNECTED AS RECOMMENDED FOR PACING OR MEASURING INTRACARDIAC ELECTROGRAMS. THIS DEVICE SHOULD BE USED ONLY BY OR UNDER THE SUPERVISION OF PHYSICIANS TRAINED IN THE TECHNIQUES OF TRANSVENOUS INTRACARDIAC STUDIES AND TEMPORARY PACING. THIS DEVICE IS FOR ONE TIME USE ONLY. REUSE OR RESTERILIZATION CAN IMPAIR THE STRUCTURAL INTEGRITY AND OR PERFORMANCE OF THE CATHETER. ADVERSE PATIENT REACTIONS CAN ALSO RESULT FROM REUSE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. THE RISKS OF USING TEMPORARY PACING CATHETERS INCLUDE THOSE RISKS RELATED TO HEART CATHETERIZATION, SUCH AS THROMBOEMBOLISM, PERFORATION, TAMPONADE, AND INFECTION. THE INDUCTION OF AN UNINTENDED ARRHYTHMIA IS A KNOWN COMPLICATION. WARNING FOR OPEN LUMEN TEMPORARY PACING ELECTRODE CATHETERS. IF USING AN OPEN LUMEN CATHETER, REMOVE ANY GUIDEWIRE STYLETTE PRIOR TO ELECTRICAL STIMULATION. WARNINGS FOR BALLOON TEMPORARY PACING ELECTRODE CATHETERS DO NOT INFLATE BALLOON BEYOND STATED MAXIMUM INFLATION CAPACITY OF 1.5 ML. BALLOON MUST BE COMPLETELY DEFLATED BEFORE WITHDRAWAL OF THE ELECTRODE CATHETER. IF THE BALLOON CATHETER HAS BEEN INFLATED IN VIVO FOR MORE THAN ONE MINUTE, COMPLETELY DEFLATE THE BALLOON AND REINFLATE IT TO THE RECOMMENDED CAPACITY OF 1.5 ML. THIS IS RECOMMENDED BECAUSE CARBON DIOXIDE DIFFUSES THROUGH THE LATEX BALLOON. PRECAUTIONS EXCESSIVE BENDING, TORQUING, OR KINKING OF THE ELECTRODE CATHETER MAY CAUSE DAMAGE TO THE CATHETER INCLUDING DAMAGE TO INTERNAL WIRES. WHEN USING A BALLOON CATHETER, USE CARE WHEN REMOVING THE PROTECTIVE SLEEVE FROM THE DISTAL PORTION OF THE CATHETER. FORCED REMOVAL OF THIS PROTECTIVE SLEEVE MAY RESULT IN DAMAGE TO THE BALLOON AND THE CATHETERS STRUCTURAL INTEGRITY. WHEN WIPING DOWN THIS CATHETER, USE ONLY STERILE SALINE. CORRECTION- D, H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.