PACEL FLOW DIRECTED PACING CATHETER

Additional Manufacturer Narrative

THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PACING ISSUE AND CARDIAC ARREST REMAINS UNKNOWN.

Description of Event or Problem

THE CATHETER WAS LEFT INSIDE THE PATIENT FOLLOWING A TAVR PROCEDURE AND THE PATIENT CODED, WAS INTUBATED AND IS NOW RECOVERING. THE CATHETER WAS GOING TO BE INSERTED WITH THE EXPECTATION OF LEAVING THE CATHETER IN THE PATIENT. PRE PROCEDURE, THE CATHETER WAS FLOATED INTO THE RV VEIN VIA INGUINAL JUGULAR ACCESS. DURING THE PROCEDURE, RAPID PACE IS SET AT 180-200 BPM DURING VALVE DEPLOYMENT AND INTERMITTENT BEATS OCCURRED. TROUBLESHOOTING WAS DONE WHICH DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS BROUGHT TO THE UNIT. A COUPLE HOURS LATER, THE DEVICE WAS STILL PACING. APPROXIMATELY AN HOUR LATER, THE PATIENT WENT INTO ASYSTOLE, THE DEVICE LOST CAPTURE AND THE PATIENT CODED AND WAS INTUBATED. THE PATIENT WAS RECOVERING AS OF (B)(6) 2023.