PIONEER PLUS CATHETER

Description of Event or Problem

IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING USE, THE CATHETER GOT STUCK ON THE NON-PHILIPS GUIDEWIRE AND HAD TO BE REMOVED AS A SYSTEM. UPON REMOVAL, DAMAGE WAS OBSERVED ON THE GUIDEWIRE. A SECOND PIONEER PLUS CATHETER WAS USED; HOWEVER, IT ENCOUNTERED THE SAME ISSUE AND REMOVED AS A SYSTEM (MDR 3008363989-2025-00141). THE PROCEDURE WAS POSTPONED FOR A LATER DATE. 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. BLOCKS A2-A6: NOT AVAILABLE FROM FACILITY. BLOCK B6 & B7: NOT AVAILABLE FROM FACILITY. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D4 & H4: THE LOT NUMBER WAS NOT PROVIDED; THUS, THE FOLLOWING INFORMATION IS UNKNOWN: UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCK H3 & H6: THE PIONEER PLUS CATHETER WAS DISCARDED; THUS, NO PRODUCT EVALUATION 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.