BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 2173051 · Received July 23, 2011

    Report

    Report Number
    3005099803-2011-02444
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    April 29, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT AGE IS UNKNOWN, THE PATIENT IS OVER 18. A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT PART OF THE PEBAX ON THE DISTAL TIP HAD DETACHED, EXPOSING THE TIP OF THE CORE WIRE. THE PTFE JACKET SHOWED NO EVIDENCE OF BEING DAMAGED AND THERE WAS NO DAMAGE FOUND TO THE COREWIRE. IT IS IMPORTANT TO MENTION THAT THE EVENT HAPPENED DURING THE PROCEDURE AND THERE IS NO ALLEGED DAMAGE IN THE WIRE PRIOR TO ITS INSERTION. THE DEVICE WAS SLIGHTLY SCRAPPED AT THE DISTAL TIP SECTION AND REMNANTS OF ADHESIVE WERE FOUND INDICATING THAT THE POLY WAS PROPERLY ATTACHED TO THE COREWIRE. IT IS POSSIBLE THAT UNSTATED PROCEDURE AND POSSIBLY CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE DISTAL TIP PEELING, INCLUDING BUT NOT LIMITED TO INTERACTION WITH OTHER DEVICES, HANDLING OF THE DEVICE AND CONDITION OF THE TREATED LESION. ADDITIONALLY THE REMNANTS OF ADHESIVE FOUND INDICATE THAT THE POLY TIP WAS PROPERLY ATTACHED TO THE COREWIRE. THEREFORE, "OPERATIONAL CONTEXT" IS THE MOST PROBABLE ROOT CAUSE FOR THIS INCIDENT. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. THESE TWO EVENTS ARE REPORTED IN MANUFACTURER REPORT # 3005099803-2011-02443 AND 3005099803-2011-02444. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE JAGWIRE GUIDEWIRES WERE ATTEMPTED TO BE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, WHILE INTRODUCTING THE FIRST JAGWIRE INTO SCOPE, THE PHYSICIAN NOTICED THAT THE TIP WAS PEELING. THE PHYSICIAN REPORTED THAT NO PART OF THE GUIDEWIRE DETACHED. THE PHYSICIAN WITHDREW THE GUIDEWIRE AND INSERTED A SECOND JAGWIRE. THE PHYSICIAN NOTED THE TIP WAS PEELING ON THE SECOND JAGWIRE AS WELL. AGAIN IT WAS CONFIRMED THAT NO PART OF THE SECOND JAGWIRE DETACHED. THE SECOND JAGWIRE WAS REMOVED AND A THIRD JAGWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION WAS REPORTED TO BE "STABLE." IT WAS ALSO REPORTED THAT THERE WAS NO RESISTANCE REMOVING THE GUIDEWIRES FROM THEIR PACKAGING. ON (B)(6) 2011, INVESTIGATION RESULTS REVEALED THAT THE TIP HAD DETACHED, MAKING THIS A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M0055658011 13456250

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS SCOPE