PIONEER PLUS CATHETER

Description of Event or Problem

IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE OF A SEVERELY CALCIFIED SFA. DURING USE, THE NON-PHILIPS GUIDEWIRE GOT STUCK AT THE CATHETER GUIDEWIRE EXIT PORT; THEREFORE, WAS REMOVED AS A SYSTEM. UPON REMOVAL, A TEAR WAS OBSERVED AT THE EXIT PORT, BUT REMAINED INTACT. THE PROCEDURE WAS COMPLETED 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: NO INFORMATION 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 NOT RETURNED BY THE FACILITY, 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.

Additional Manufacturer Narrative

BLOCKS D9 & H3: THE PIONEER PLUS CATHETER WAS RETURNED FOR EVALUATION. BLOCK H3: THE PIONEER PLUS CATHETER WAS RETURNED WITHOUT THE NON-PHILIPS GUIDEWIRE. VISUAL INSPECTION FOUND A SLIGHTLY BENT SCANNER, LIFTED ADHESIVE AT THE DISTAL FILLET, AND SCRATCHES WERE PRESENT AT THE DISTAL TIP AND SHAFT. NO FUNCTIONAL TESTING WAS PERFORMED. BLOCK H6: BASED ON THE DEVICE EVALUATION, THE PROBABLE CAUSE OF THE REMOVAL AS A SYSTEM IS LIKELY DUE TO THE DAMAGE OBSERVED. MANIPULATION, IMPACT AND APPLIED PRESSURE ASSOCIATED WITH USE AND HANDLING CAN FURTHER AFFECT THE INTEGRITY OF THE DEVICE. 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.