UNKNOWN TEMPORARY PACING ELECTRODE

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTIONS 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 BY CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY STATED THAT NO, THE TEMPORARY PACING ELECTRODE (TPE) CATHETER COULD NOT BE SUCCESSFULLY PLACED BECAUSE THAT WAS ONLY TEMPORARY IN RELATION TO BALLOON RIGHT HEART CURVE TPE, MENTIONING THAT THE DEVICE WAS USED FOR 1 DAY. ADDITIONALLY IN CHART 1 A PHYSICIAN STATED THAT NO, THE TEMPORARY PACING ELECTRODE (TPE) CATHETER WAS NOT ABLE TO SUCCESSFULLY CAPTURE AND PACE FOR THE CHOSEN DURATION OF USE BECAUSE THAT WAS ONLY TEMPORARY IN RELATION TO BALLOON RIGHT HEART CURVE TPE, MENTIONING THAT THE DEVICE WAS USED FOR 1 DAY.