PIONEER PLUS CATHETER

Additional Manufacturer Narrative

BLOCK H3: THE PIONEER PLUS CATHETER WAS RETURNED INTACT TO A NON-PHILIPS GUIDEWIRE. VISUAL INSPECTION FOUND NO DAMAGE ON THE CATHETER OR THE GUIDEWIRE. THE GUIDEWIRE WAS STUCK AT THE CATHETER LUER SECTION AND COULD NOT BE REMOVED; THEREFORE, NO FUNCTIONAL TESTING WAS DONE IN THIS AREA. HOWEVER, A GUIDE WIRE MOVEMENT TEST WAS PERFORMED BY INSERTING A LABORATORY GUIDEWIRE THROUGH THE CATHETER DISTAL TIP AND EXITED OUT THE RX PORT WITH NO RESISTANCE ENCOUNTERED. BLOCK H6: THE PROBABLE CAUSE OF THE REPORTED FAILURE (REMOVAL AS A SYSTEM) IS LIKELY DUE TO USE HANDLING. STRAIN, IMPACT, AND FORCES ASSOCIATED WITH USE CAN 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 IN A THERAPEUTIC PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED POPLITEAL. DURING USE, THE NON-PHILIPS GUIDEWIRE GOT STUCK ON THE CATHETER; THEREFORE, WAS REMOVED AS A SYSTEM. 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 A6: NOT AVAILABLE FROM THE FACILITY. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. 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.