BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 2163023 · Received July 15, 2011

    Report

    Report Number
    3005099803-2011-02388
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 6, 2011
    Report Date
    June 17, 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 PATIENT AGE IS UNKNOWN, THE PATIENT IS (B)(6). (B)(4). A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT 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 DURING REMOVAL OF THE DEVICE FROM PACKAGING HOOP, THE DEVICE MAY BECOME HUNG UP ON THE EDGE OF THE DISPENSER TUBE AND MAY HAVE BEEN PULLED AGAINST RESISTANCE THAT COMPROMISES THE INTEGRITY OF THE TIP, THEREBY CAUSING THE DAMAGED REPORTED. ADDITIONALLY THE REMNANTS OF ADHESIVE FOUND INDICATE THAT THE POLY TIP WAS PROPERLY ATTACHED TO THE COREWIRE. THEREFORE, "HANDLING DAMAGE" 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 THREE COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-02386, AND 3005099803-2011-02442 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A THREE JAGWIRE GUIDEWIRES WERE ATTEMPTED TO BE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINT, DURING UNPACKING FOR THE PROCEDURE, THREE GUIDEWIRES WERE REMOVED FROM THEIR PACKAGING AND THE DOCTOR NOTICED THAT SOME PART OF THE TIP WAS NOT INTACT. THERE WAS NO DAMAGE REPORTED TO THE PACKAGES. A FOURTH JAGWIRE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "STABLE." 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