PACEL BIPOLAR PACING CATHETER

Description of Event or Problem

IT WAS REPORTED THAT THE PACEL FLOW DIRECTED PACING CATHETER WAS NOT PACING WHILE THE BALLOON WAS INFLATED. THE PATIENT WAS EXPERIENCING LOSS OF CAPTURE AND BECAME HEMODYNAMICALLY UNSTABLE. THE PHYSICIAN WAS NOTIFIED AND AN ATTEMPT WAS MADE TO REPOSITION THE TRANSVENOUS PACING LINE WITHOUT SUCCESS. THE PACING CATHETER WAS REPLACED TO RESOLVE THE ISSUE. FURTHER INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE PACEL FLOW DIRECTED PACING CATHETER WAS NOT PACING WHILE THE BALLOON WAS INFLATED. THE PATIENT WAS EXPERIENCING LOSS OF CAPTURE AND BECAME HEMODYNAMICALLY UNSTABLE. THE PHYSICIAN WAS NOTIFIED AND AN ATTEMPT WAS MADE TO REPOSITION THE TRANSVENOUS PACING LINE WITHOUT SUCCESS. THE PACING CATHETER WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9 (DEVICE DISCARDED), H6, H11. CORRECTION: B1 (REMOVED ADVERSE EVENT), H1 (CHANGE FROM SERIOUS INJURY TO MALFUNCTION). THE DEVICE WAS NOT RETURNED FOR 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 INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED PACING PROBLEM COULD NOT BE DETERMINED. IN THIS CASE, IT IS POSSIBLE THAT THE PACING PROBLEM IS DUE TO DAMAGE TO THE DEVICE OR DEVICE COMPONENT; HOWEVER, SINCE THE DEVICE WAS NOT RETURNED THIS COULD NOT BE CONFIRMED. 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.