BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC BILIARY CATHETER

    MDR report key: 1983617 · Received February 10, 2011

    Report

    Report Number
    3005099803-2011-00215
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    November 29, 2010
    Report Date
    January 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQR
    PMA / PMN Number
    K946358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION REVEALED THAT THE WORKING LENGTH WAS TWISTED AND RESIDUE WAS PRESENT, WHICH INDICATES USAGE/HANDLING OF THE DEVICE. THE EXPOSED CUT WIRE WAS DISCOLORED AND APPEARED TO HAVE MELTED/SPLIT THE EXTRUSION AT THE DISTAL PIERCE HOLE. THE MELTED EXTRUSION, CREATED A TEAR MEASURING APPROXIMATELY 4 MM PROXIMALLY FROM THE DISTAL PIERCE HOLE. THIS TEAR CAUSED THE CUTTING WIRE ANCHOR TO SLIDE PROXIMALLY FROM THE DISTAL PIERCE HOLE AND SHORTENED THE EXPOSED CUTTING WIRE LENGTH, WHICH NOW DOES NOT MEET SPECIFICATION. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE DID NOT MEET THE BOWING SPECIFICATION AS A RESULT OF THE MELTED/SPLIT EXTRUSION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE WOULD NOT BOW, HOWEVER, THIS WAS ATTRIBUTED TO MELTED/SPLIT EXTRUSION. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED, THE MELTED/SPLIT EXTRUSION IS LIKELY DUE TO HANDLING. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN STONETOME SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC SPHINCTERECTOMY (EST) PROCEDURE.ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION THE DEVICE WAS UNABLE TO TIGHTEN (BOW). THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME SPHINCTEROTOME.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; MELTED/SPLIT EXTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC BILIARY CATHETER DISLODGER, STONE, BILIARY LQR BOSTON SCIENTIFIC - SPENCER M00535110 13585027

    Patients

    Seq Age Sex Outcome Treatment
    1