PIONEER PLUS CATHETER

Additional Manufacturer Narrative

THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCK A2, A3B: NO INFORMATION AVAILABLE. BLOCKS B6 & B7: NO INFORMATION AVAILABLE. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCK G2: USER FACILITY REPORT # (B)(4). BLOCKS H3 & H6: THE PIONEER CATHETER WAS DISCARDED; THUS, NO PRODUCT INVESTIGATION WAS PERFORMED. BLOCKS H7, H9 & H10: DO NOT APPLY TO THIS SUBMISSION. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

Description of Event or Problem

IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED DURING A PERIPHERAL PROCEDURE. WHEN REMOVING THE CATHETER FROM THE NON-PHILIPS GUIDEWIRE (BOSTON SCIENTIFIC THRUWAY), THE TIP OF THE GUIDEWIRE SHEARED OFF INSIDE THE PATIENT. ATTEMPTS WERE MADE TO RETRIEVE THE SEPARATED PORTION, BUT IT REMAINED IN THE DISSECTED PLAIN OF THE SFA. THE CAUSE OF THE GUIDEWIRE SEPARATION IS UNKNOWN; HOWEVER, THERE WAS NO ALLEGED MALFUNCTION OF THE PIONEER PLUS CATHETER. THIS ADVERSE EVENT IS BEING SUBMITTED CONSERVATIVELY BECAUSE IT IS UNKNOWN IF THE SHARP EDGE OF THE NEEDLE POSSIBLY CAUSED OR CONTRIBUTED TO THE GUIDEWIRE SEPARATION, REQUIRING INTERVENTION BUT RETAINED IN PATIENT.