PIONEER PLUS CATHETER

Description of Event or Problem

IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED MID SFA. DURING USE, THE CATHETER GOT STUCK ON A NON-PHILIPS GUIDEWIRE (MDR 3008363989-2025-00134); THEREFORE, WAS REMOVED AS A SYSTEM. A NEW PIONEER CATHETER WAS OPENED; HOWEVER, WHILE PULLING BACK THE GUIDEWIRE FROM THE NEEDLE PORT, A PIECE OF THE GUIDEWIRE WAS SHEARED BUT REMAINED INTACT. AS A RESULT, BOTH THE CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM. A THIRD PIONEER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PIONEER PLUS CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

Additional Manufacturer Narrative

THIS COMPLAINT WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCK A4: NOT AVAILABLE FROM THE FACILITY. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCKS H3 & H6: THE PIONEER PLUS CATHETER WAS DISCARDED, THUS NO PRODUCT INVESTIGATION 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.