PACEL FLOW DIRECTED PACING CATHETER

Description of Event or Problem

IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE PREPARATION A PACEL CATHETER WAS USED; HOWEVER, BALLOON ADVANCEMENT FAILED. WHILE PASSING THE CATHETER THROUGH THE SHEATH, THE BALLOON COULD NOT PASS THE GREEN HUB. THE CATHETER WAS NOT USED IN THE PATIENT. A NEW PACEL CATHETER WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANALYSIS OBSERVED A BALLOON DETACHMENT. THE DATE OF EVENT WILL BE ESTIMATED AS (B)(6) 2026.

Additional Manufacturer Narrative

A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULT TO ADVANCE COULD NOT BE CONFIRMED THROUGH ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULT TO ADVANCE COULD NOT BE DETERMINED. HOWEVER, THE BALLOON IS SEPARATED FROM THE CATHETER. IT APPEARS TO HAVE BEEN DISLODGED FROM BOTH THE PROXIMAL AND DISTAL CIRCUMFERENTIAL GLUE BONDS. THE SEPARATED BALLOON MAY HAVE CONTRIBUTED TO THE DIFFICULTY PASSING THE CATHETER THROUGH THE SHEATH. THE ROOT CAUSE OF THE BALLOON SEPARATION WAS UNABLE TO BE CONCLUSIVELY DETERMINED. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.