PIONEER PLUS CATHETER

Additional Manufacturer Narrative

THIS COMPLAINT WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCKS A3B: NOT AVAILABLE FROM FACILITY. BLOCK B6: NOT AVAILABLE FROM FACILITY. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCK H3: THE PIONEER PLUS CATHETER WAS RETURNED INTACT TO A NON-PHILIPS GUIDEWIRE. VISUAL INSPECTION FOUND SCRATCHES ON THE DISTAL TIP AND DISTAL SLEEVE. AN ATTEMPT WAS MADE TO REMOVE THE GUIDEWIRE BUT COULD NOT BE REMOVED, DAMAGING THE GUIDEWIRE EXIT PORT. GUIDEWIRE MOVEMENT TEST COULD NOT BE PERFORMED DUE TO THE STUCK GUIDEWIRE. BLOCK H6: THE PROBABLE CAUSE OF THE REPORTED FAILURE IS DAMAGE DURING USE/HANDLING, AS EVIDENCED BY THE STUCK GUIDE WIRE. 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 FOR A PERIPHERAL PROCEDURE IN A DISTAL SFA. DURING ADVANCEMENT OVER A NON-PHILIPS GUIDEWIRE, RESISTANCE WAS FELT AND THE CATHETER COULD NOT BE ADVANCED OR RETRACTED. UNDER FLUOROSCOPY, THE GUIDEWIRE APPEARED PROLAPSED AND KINKED; THEREFORE, THE CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER WITHIN THE SHEATH. THE PROCEDURE WAS ABORTED AND THE PATIENT WILL BE BROUGHT BACK AT 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.