GOETZ¿ 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 IN THE ONLINE SURVEY A PHYSICIAN STATED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE "5F 100CM GOETZ TEMPORARY PACING ELECTRODE CATHETER, BIPOLAR" WITH PRODUCT CODE 007154P, AND THE PATIENT EXPERIENCED "TAMPONADE" AND IT DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.

Additional Manufacturer Narrative

THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS, AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: 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. REUSE OR RE STERILIZATION 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. AFTER INITIAL INSERTION OF THE NEEDLE, DO NOT ATTEMPT TO REINSERT ONCE PARTIALLY OR COMPLETELY WITHDRAWN. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE, AND FEDERAL LAWS. 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. THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS. 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. INSTRUCTIONS FOR USE INSPECTION INSTRUCTIONS 1. VISUALLY INSPECT THE CATHETER, UNDER STERILE CONDITIONS, FOR KINKS IN THE CATHETER SHAFT, INTEGRITY OF THE CONNECTOR, CONDITION OF ELECTRODES, AND ANY OTHER DAMAGE. 2. IN CASE OF CATHETERS WITH A BALLOON, UNDER STERILE CONDITIONS, REMOVE THE PROTECTIVE SHEATH AND INFLATE THE BALLOON WITH 1.5 ML OF AIR OR CARBON DIOXIDE. USE THE INFLATION SYRINGE INCLUDED IN THE PACKAGE. COMPLETELY DEFLATE THE BALLOON AFTER THE TEST. INSERTION INSTRUCTIONS USING A NEEDLE CANNULA 1. OPEN THE PACKAGE AND PLACE THE CONTENTS ON A STERILE FIELD. 2. PREP THE SKIN AT THE SITE OF INSERTION AND INJECT WITH A LOCAL ANESTHETIC. 3. REMOVE THE PROTECTIVE GUARD FROM THE NEEDLE CANNULA. 4. ENTER THE VEIN WITH THE NEEDLE CANNULA. SIMULTANEOUS ASPIRATION INTO A SYRINGE WILL HELP CONFIRM VESSEL ENTRY. 5. REMOVE THE SYRINGE AND THE NEEDLE. 6. USING THE AID OF FLUOROSCOPY OR AN ECG MONITOR, ADVANCE THE CATHETER THROUGH THE CANNULA TO THE DESIRED POSITION. IF USING A BALLOON CATHETER, INFLATE THE BALLOON WHEN THE CATHETER IS IN THE RIGHT ATRIUM. PLEASE NOTE THAT THE BALLOON CAN BE INFLATED OR DEFLATED ONLY WHEN THE STOPCOCK IS PARALLEL TO THE CATHETER SHAFT. DO NOT PULL THE CATHETER BACK THROUGH THE CANNULA AS IT MAY CAUSE DAMAGE TO THE CATHETER. 7. IF USING A BALLOON CATHETER, DEFLATE THE BALLOON AFTER THE CATHETER HAS REACHED THE DESIRED LOCATION. 8. TEST THE PACING CHARACTERISTICS FOR OPTIMAL PACING. 9. PULL THE CANNULA BACK AND SECURE IT TO THE PROXIMAL END OF THE CATHETER. 10. SECURE THE ELECTRODE CATHETER IN PLACE AT THE INSERTION SITE. INSERTION INSTRUCTIONS USING A PERCUTANEOUS INTRODUCER SHEATH FOLLOW THE INSTRUCTIONS, WARNINGS, AND PRECAUTIONS OF THE INTRODUCER MANUFACTURER. IF USING A BALLOON TEMPORARY PACING CATHETER, USE HALF OR ONE FRENCH SIZE LARGER INTRODUCER, UNLESS OTHERWISE RECOMMENDED BY THE INTRODUCER MANUFACTURER. ELECTRICAL CONNECTIONS FOR MEASURING INTRACARDIAC ECGS 1. INSERT ADAPTER PIN INTO STANDARD 2 MM (0.080¿) PIN RECEPTACLE OF EQUIPMENT (SEE FIGURE 1). IF EQUIPMENT CONTAINS A LOCKING MECHANISM SUCH AS A COLLET OR THUMBSCREW, TIGHTEN DOWN ONTO ADAPTER. LEAVE AFFIXED TO EQUIPMENT. WARNING: INAPPROPRIATE ELECTRICAL CONNECTIONS, E.G. INTO A WALL SOCKET, MAY POSE SERIOUS RISK OF ADVERSE HEALTH CONSEQUENCES OR DEATH. 2. THREAD LEADS OF CATHETER THROUGH THE ADAPTER EYELET. CONNECT THE NEGATIVE JACK (MARKED ¿DISTAL¿) TO THE V-LEAD OF THE ECG, AND THE POSITIVE JACK (UNMARKED) TO THE POSITIVE TERMINAL OF THE EXTERNAL PULSE GENERATOR. ELECTRICAL CONNECTIONS FOR PACING 1. INSERT ADAPTER PIN INTO STANDARD 2 MM (0.080¿) PIN RECEPTACLE OF EQUIPMENT (SEE FIGURE 1). IF EQUIPMENT CONTAINS A LOCKING MECHANISM SUCH AS A COLLET OR THUMBSCREW, TIGHTEN DOWN ONTO ADAPTER. LEAVE AFFIXED TO EQUIPMENT. WARNING: INAPPROPRIATE ELECTRICAL CONNECTIONS, E.G. INTO A WALL SOCKET, MAY POSE SERIOUS RISK OF ADVERSE HEALTH CONSEQUENCES OR DEATH. 2. THREAD LEADS OF CATHETER THROUGH THE ADAPTER EYELET. CONNECT THE NEGATIVE JACK (MARKED DISTAL) TO THE NEGATIVE TERMINAL OF THE EXTERNAL PULSE GENERATOR, AND THE POSITIVE JACK (UNMARKED) TO THE POSITIVE TERMINAL OF THE PULSE GENERATOR. CORRECTION: B 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 IN THE ONLINE SURVEY A PHYSICIAN STATED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE "5F 100CM GOETZ TEMPORARY PACING ELECTRODE CATHETER, BIPOLAR" WITH PRODUCT CODE 007154P, AND THE PATIENT EXPERIENCED "TAMPONADE" AND IT DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.