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 CRITICAL CARE PHYSICIAN IN AN ONLINE SURVEY REPORTED THAT THE ELECTRODE WAS NOT SUCCESSFULLY ABLE TO CAPTURE AND PACE FOR THE CHOSEN DURATION OF USE BECAUSE "LEAD DISPLACEMENT" IN RELATION TO 5F 110CM BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, RIGHT HEART CURVE.

Additional Manufacturer Narrative

THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THE 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. THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: INSTRUCTIONS FOR USE - INSPECTION INSTRUCTIONS - 1. INSPECT THE STERILE PACKAGE CAREFULLY FOR DAMAGE DURING TRANSIT OR STORAGE. DO NOT USE THE CATHETER IF THE PACKAGE IS DAMAGED. 2. VISUALLY INSPECT THE CATHETER, UNDER STERILE CONDITIONS, FOR KINKS IN THE CATHETER SHAFT, INTEGRITY OF THE CONNECTOR, CONDITION OF ELECTRODES, AND ANY OTHER DAMAGE. 3. 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 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. IF USING AN OPEN-LUMEN CATHETER, FLUSH THE CATHETER WITH A HEPARINIZED SOLUTION. REMOVE ANY STYLETTE PRIOR TO INSERTION. 7. 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. 8. IF USING A BALLOON CATHETER, DEFLATE THE BALLOON AFTER THE CATHETER HAS REACHED THE DESIRED LOCATION. 9. TEST THE PACING CHARACTERISTICS FOR OPTIMAL PACING. 10. PULL THE CANNULA BACK AND SECURE IT TO THE PROXIMAL END OF THE CATHETER. 11. 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. 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 CRITICAL CARE PHYSICAN IN AN ONLINE SURVEY REPORTED THAT THE ELECTRODE WAS NOT SUCCESSFULLY ABLE TO CAPTURE AND PACE FOR THE CHOSEN DURATION OF USE¿ BECAUSE "LEAD DISPLACEMENT" IN RELATION TO 5F 110CM BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, RIGHT HEART CURVE.