PIONEER PLUS CATHETER

Description of Event or Problem

IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A PERIPHERAL PROCEDURE. DURING ADVANCEMENT, THE TIP OF THE NEEDLE GOT CAUGHT, EXPOSING THE NEEDLE AND COULD NOT BE RETRACTED. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO A SHARP EDGE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WAS TO RECUR.

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. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCKS H3 & H6: THE PIONEER PLUS CATHETER WAS NOT RETURNED, 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.