PIONEER PLUS CATHETER

Additional Manufacturer Narrative

THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCKS A2-A6: NOT AVAILABLE FROM FACILITY. BLOCK B6 & B7: NOT AVAILABLE FROM FACILITY. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCK H3 & H6: THE PIONEER CATHETER WAS INFECTIOUS AND DISCARDED BY THE FACILITY, 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 IN A PERIPHERAL THERAPEUTIC PROCEDURE. DURING USE, RECOGNITION WAS SUCCESSFUL; HOWEVER, THE IMAGE WAS LOST WHEN ADVANCING TO THE VESSEL. THE CATHETER WAS UNPLUGGED/PLUGGED, BUT STILL DID NOT WORK. THE USE OF THE CATHETER WAS ABORTED AND THE PHYSICIAN DECIDED TO PERFORM SURGERY TO COMPLETE THE PROCEDURE. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE PIONEER CATHETER COULD NOT BE USED; THEREFORE, SURGICAL INTERVENTION WAS PERFORMED.