PIONEER PLUS CATHETER

Additional Manufacturer Narrative

THIS COMPLAINT WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCKS A4: WEIGHT, 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 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 THERAPEUTIC PERIPHERAL PROCEDURE IN SEVERELY CALCIFIED SFA. DURING USE, WHEN THE CATHETER WAS ADVANCED TO THE OCCLUSION, THE IVUS IMAGE WAS LOST. THE SYSTEM WAS REBOOTED, CATHETER WAS UNPLUGGED/PLUGGED; HOWEVER, THE IMAGE REMAINED LOST. THE PROCEDURE COULD NOT BE COMPLETE BECAUSE THEY COULD NOT CROSS BACK INTO THE TRUE LUMEN WITHOUT THE CATHETER. THE PATIENT WILL BE BROUGHT BACK FOR TREATMENT AT 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.