Description of Event or Problem · 1
SAME CASE AS MFR REPORT# 3005099803-2008-04631. IT WAS REPORTED THAT DURING AN UNSPECIFIED BILIARY PROCEDURE, GUIDE WIRE COATING DETACHMENTS OCCURRED. THE STONES WERE LOCATED IN THE COMMON BILE DUCT (CBD). AT AN UNSPECIFIED TIME DURING THE PROCEDURE, IT WAS NOTED THAT THE 0.035 JAG PRECURSOR GUIDE WIRE WAS UNABLE TO BE WITHDRAWN FROM ANOTHER MANUFACTURER'S GUIDE CATHETER. IT WAS NOTED THAT SOME OF THE GUIDE WIRE'S COATING HAD DETACHED AND REMAINED INSIDE THE GUIDE CATHETER. IT WAS NOTED THAT THE CATHETER WAS A REUSABLE CATHETER WHICH HAD ALREADY BEEN USED. A SECOND 0.035 JAG PRECURSOR GUIDE WIRE WAS ADVANCED, HOWEVER, THE SAME ISSUE OCCURRED. IT WAS NOT KNOWN HOW THESE DEVICES WERE REMOVED. IT WAS NOTED THAT THE DAMAGED PORTION OF THE GUIDE WIRE REMAINED INSIDE THE CATHETER. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS UNKNOWN.