NBIH¿ 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 TEMPORARY PACING ELECTRODE CATHETER COULD NOT REACH AN OUTPUT OF MORE THAN 15 SO NO CHANGE IN THE WIRES WAS OBSERVED AND THE PROBLEM. IT WAS NOTED THAT THE GIVEN LOT# WAS GFFS2570.

Description of Event or Problem

IT WAS REPORTED THAT TEMPORARY PACING ELECTRODE CATHETER COULD NOT REACH AN OUTPUT OF MORE THAN 15 SO NO CHANGE IN THE WIRES WAS OBSERVED AND THE PROBLEM. IT WAS NOTED THAT THE GIVEN LOT# WAS GFFS2570. PER ADDITIONAL INFORMATION RECEIVED 16MAY2025, STATED THAT THE PACING ELECTRODE IS NOT CAPTURING DESPITE THE OUTPUT BEING SET TO 15; NO SPIKE WAS VISUALIZED THE GENERATOR AND CONNECTOR CABLE WERE REPLACED, BUT THE PROBLEM PERSISTS.

Additional Manufacturer Narrative

THE REPORTED EVENT WAS CONFIRMED CAUSE UNKNOWN. SAMPLE EVALUATION RESULTS: THE RETURNED SAMPLE WAS TESTED FOR ELECTRICAL RESISTANCE USING TEST BOX T-657, CALIBRATED (B)(6) 2026, DUE 1/2027, MULTIMETER T-402, CALIBRATED (B)(6) 2026, DUE 1/2027. BOTH WERE UTILIZED TO TEST THE FUNCTIONALITY OF BOTH THE DISTAL AND PROXIMAL ELECTRODES. ELECTRODES LOOK ACCEPTABLE - NO SCRATCHES ETC. IT WAS OBSERVED THAT CO WAS ON THE EDGES OF THE ELECTRODES, BUT THE WORKING AREA OF THE ELECTRODES WAS NOTED TO NOT HAVE CO AND WAS FOUND TO BE ACCEPTABLE. THE RESULTS OF THE RESISTANCE TEST ARE SHOWN BELOW (SEE FIGURES 1 AND 2). CIRCUIT #1 (DISTAL ELECTRODE) ¿ 1.4 OHMS, CIRCUIT #2 (PROXIMAL ELECTRODE) ¿0.0 OHMS. FIGURE 1: RESISTANCE TEST BEING PERFORMED ON THE DISTAL ELECTRODE. FIGURE 2: RESISTANCE TEST BEING PERFORMED ON THE PROXIMAL ELECTRODE. NOTE: ELECTRICAL RESISTANCE: PER SPECIFICATION RESISTANCE MUST BE GREATER THAN 0 BUT LESS THAN 30 OHMS. SAMPLE EVALUATION CONCLUSIONS: RESULTS OF THE SAMPLE EVALUATION INDICATE THAT ELECTRICAL CONTINUITY IS PRESENT IN THE DISTAL ELECTRODE. HOWEVER, THE PROXIMAL ELECTRODE EXHIBITS A RESISTANCE READING CONSISTENT WITH A SHORT CIRCUIT. THUS, THE REVIEW OF THE CATHETER INDICATED THE COMPLAINT IS CONFIRMED; THE COMPLAINT SAMPLE DOES EXHIBIT THE FAILURE CONDITION ALLEGED BY THE COMPLAINT. INVESTIGATION SUMMARY: REVIEW OF THE SAMPLE CONFIRMED THE ALLEGED CONCERN. HOWEVER, BASED ON THE AVAILABLE DATA AND THE ABSENCE OF DEFINITIVE EVIDENCE, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED OR ATTRIBUTED TO MANUFACTURING. CORRECTIONS MADE TO TAB(S) D AND 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.