PIONEER PLUS CATHETER

Additional Manufacturer Narrative

THIS COMPLAINT WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCKS A2 & A3B-A6: NOT AVAILABLE FROM FACILITY. BLOCKS B6 & B7: NOT AVAILABLE FROM FACILITY. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D4 & H4: THE LOT NUMBER WAS NOT PROVIDED, THUS THE FOLLOWING INFORMATION IS UNKNOWN: UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCKS H3 & H6: THE PIONEER PLUS CATHETER WAS NOT RETURNED FOR EVALUATION, 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.

Description of Event or Problem

IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A PROCEDURE. DURING USE, THE CATHETER PRODUCED POOR IMAGE QUALITY; HALF BLANK AND HALF ARTIFACTS. THE PROCEDURE WAS RESCHEDULED FOR A LATER DATE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE CATHETER COULD NOT BE USED; RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.