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 (MDR 3008363989-2025-00140). 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. 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, AND FOR DELAY OF PROCEDURE. 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.