PIONEER PLUS CATHETER

Additional Manufacturer Narrative

BLOCK H3: THE PIONEER PLUS CATHETER WAS RETURNED WITHOUT THE NON-PHILIPS GUIDEWIRE. VISUAL INSPECTION FOUND A DAMAGED RX EXIT PORT, WHICH ALIGNS WITH THE REPORTED COMPLAINT THAT A BUMP WAS PRESENT ON THE MONORAIL (EXIT PORT). DURING FUNCTIONAL TESTING, THE CATHETER FAILED THE GUIDEWIRE MOVEMENT TEST DUE TO RESISTANCE ENCOUNTERED. BLOCK H6: THE PROBABLE CAUSE OF THE REPORTED FAILURE (REMOVAL AS A SYSTEM) IS DAMAGE DURING USE/HANDLING. MANIPULATION, STRAIN, IMPACT, AND APPLIED FORCE 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.

Description of Event or Problem

IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED FOR A PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED SFA. DURING ADVANCEMENT, THE CATHETER GOT STUCK ON THE NON-PHILIPS WIRE; THEREFORE, REMOVED AS A SYSTEM. ADDITIONALLY, IT WAS NOTED THAT THE CATHETER HAD A BUMP ON THE MONORAIL, WHERE THE WIRE COMES OUT. A NEW 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 A3B: NOT PROVIDED BY 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, 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.