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 THEY PRE-INFLATED THE BALLOON AND IT DID INFLATE BUT WAS "CROOKED". THEY USED THE PRODUCT ON THE ON THE PATIENT AND THE BALLOON RUPTURED IN THE PATIENT. INQUIRED IF IT CAUSED HARM TO THE PATIENT AND SHE STATED IT DID NOT.

Description of Event or Problem

IT WAS REPORTED THAT THEY PRE-INFLATED THE BALLOON AND IT DID INFLATE BUT WAS "CROOKED". THEY USED THE PRODUCT ON THE ON THE PATIENT AND THE BALLOON RUPTURED IN THE PATIENT. INQUIRED IF IT CAUSED HARM TO THE PATIENT AND SHE STATED IT DID NOT.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS CONFIRMED, CAUSE UNKNOWN. RECEIVED 1 TEMPORARY PACING ELECTRODE CATHETER. VISUAL INSPECTION NOTED THAT THE BALLOON WAS RUPTURED CONFIRMING THE REPORTED EVENT. EVENT DESCRIPTION: ¿IT WAS REPORTED THAT THEY PRE INFLATED THE BALLOON AND IT DID INFLATE BUT WAS "CROOKED". THEY USED THE PRODUCT ON THE ON THE PATIENT AND THE BALLOON RUPTURED IN THE PATIENT. INQUIRED IF IT CAUSED HARM TO THE PATIENT AND SHE STATED IT DID NOT.¿ PRELIMINARY EVALUATION: ONE SAMPLE (CATALOG NUMBER 006173P 5F 110CM BALLOON PACING ELECTRODE) CATHETER WAS RETURNED ON TUESDAY (B)(6) 2026, PER FEDEX TRACKING NUMBER (B)(4). THE FOLLOWING SAMPLE OBSERVATIONS WERE NOTED: SAMPLE WAS RETURNED COILED UP IN A ZIPLOC BAG WRITTEN ON THE OUTSIDE OF THE BAG. A STICKER WAS AFFIXED ON THE POLYBAG SHOWING THAT IT WAS PROCESSED BY EO STERILIZATION WB ON (B)(6) 2025. THE SAMPLE DID NOT INCLUDE THE SAFETY ADAPTERS. NO PACKAGING LABELING WAS RETURNED. A 3ML SYRINGE WAS ATTACHED TO THE PROXIMAL LEG. THE LUER LOCK WAS IN THE CLOSED POSITION. THE BALLOON WAS RUPTURED. THERE WAS NO DAMAGE NOTED TO THE CATHETER. NO FOREIGN MATTER WAS OBSERVED ON THE UNIT. TRACE AMOUNTS OF BLOOD WERE OBSERVED ON THE RETURNED SAMPLE AND ARE CONSISTENT WITH NORMAL CLINICAL USE. SAMPLE EVALUATION RESULTS: THE RETURNED SAMPLE WAS NOT FUNCTIONALLY TESTED DUE TO THE CONDITION OF THE BALLOON. A VISUAL INSPECTION WAS PERFORMED, AND NO SUBSTANTIAL OR OUT OF THE ORDINARY CONDITIONS WERE OBSERVED THAT COULD BE CONCLUSIVELY INFERRED FROM THE CONDITION OF THE BALLOON. IT WAS NOTED THAT THE BALLOON TIE IN THE PROXIMAL AREA APPEARED MORE STRETCHED, COMPARED TO THE TIE IN THE DISTAL AREA. HOWEVER, BASED ON ESTABLISHED MANUFACTURING CONTROLS FOR THIS ATTRIBUTE AND THE POSSIBILITY THAT POST MANUFACTURING HANDLING OR DEVICE USE MAY HAVE CONTRIBUTED TO THE OBSERVED VARIATION, THIS OBSERVATION WAS NOT CONSIDERED CONCLUSIVE. FIGURE 1: BALLOON TIE AREA OF THE SAMPLE, PROXIMAL TIE AREA HIGHLIGHTED. SAMPLE EVALUATION CONCLUSIONS: REVIEW OF THE CATHETER INDICATED THE COMPLAINT IS CONFIRMED, THE COMPLAINT SAMPLE DOES EXHIBIT THE FAILURE CONDITION ALLEGED BY THE COMPLAINT. THE DEVICE HISTORY RECORDS HAVE NOT BEEN REVIEWED AS THE BATCH NUMBER GFKS0588 PROVIDED DOES NOT MATCH THE GIVEN CATALOG NUMBER(006173P). THEREFORE, THE RECORD IS UNKNOWN AT THIS TIME. INVESTIGATION SUMMARY: THE COMPLAINT SAMPLE DOES EXHIBIT THE FAILURE CONDITION ALLEGED BY THE COMPLAINT. THEREFORE, THE COMPLAINT IS CONFIRMED. IT IS POSSIBLE THAT PATIENT OR PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE ALLEGED EVENT. A REVIEW OF MANUFACTURING DOCUMENTATION COULD NOT BE REVIEWED TO INDICATE IF A MANUFACTURING RELATED CAUSE WAS POSSIBLE FOR THESE EVENTS. DHR WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. CORRECTIONS MADE TO TAB(S) D, F, 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.