PIONEER PLUS CATHETER

Additional Manufacturer Narrative

THIS COMPLAINT WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCKS A2-A6: NOT AVAILABLE FROM FACILITY. BLOCKS B6 & B7: NOT AVAILABLE FROM FACILITY. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCK D4: SERIAL # NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCKS H3 & H6: THE PIONEER PLUS CATHETER WAS DISCARDED, THUS NO PRODUCT INVESTIGATION 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.

Description of Event or Problem

IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED FOR A PERIPHERAL PROCEDURE IN SEVERELY CALCIFIED SFA. DURING USE, THE CATHETER WAS DEFECTIVE DUE TO THE ULTRASOUND NOT WORKING. UPON REMOVAL, THE CATHETER BECAME TANGLED/KINKED, AND THE GUIDEWIRE TORE THROUGH PART OF THE CATHETER; THEREFORE, REMOVED TOGETHER. AT THIS POINT, THE PHYSICIAN DECIDED IT WAS BETTER TO DISCONTINUE THE PROCEDURE AND BRING THE PATIENT 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.