BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE¿

    MDR report key: 2961573 · Received February 14, 2013

    Report

    Report Number
    3005099803-2013-00695
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF COREWIRE FRACTURE. A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE GUIDEWIRE HAD SEPARATED INTO TWO SECTIONS. AN ANALYSIS OF THE FRACTURE SITE REVEALED TENSION AND COMPRESSION ZONES; FAILURES SURFACE SHOWED TRANSVERSAL MARK POINTING TO A BENDING OVERLOAD EVENT, ALSO SHOWED EVIDENCE OF EQUIAXIAL DIMPLES RUPTURE, MOST PROBABLY DUE TO A TENSION OVERLOAD EVENT. THE OUTER DIAMETER OF THE GUIDEWIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. ASSORTED ANATOMICAL AND PROCEDURAL ISSUE COULD HAVE CONTRIBUTED TO THE DIFFICULTY WITHDRAWING OF THE WIRE, THEREFORE, PERFORMANCE WAS LIMITED AND MAY HAVE CONTRIBUTED TO FAILURE. 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. A SIMILAR COMPLAINT TREND REVIEW WAS PERFORMED AND NO OTHER COMPLAINTS WERE REPORTED FOR LOT NUMBER 15412514.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EDG) PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE THE GUIDEWIRE WAS BEING REMOVED FROM A PEG J-TUBE, THE GUIDEWIRE PEELED NEAR A KNOT LIKE LUMP NOTED ON THE GUIDEWIRE. IT WAS REPORTED THAT NO PART OF THE GUIDEWIRE DETACHED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGWIRE AND THE SAME J-TUBE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS FINE. ON (B)(4) 2013, INVESTIGATION RESULTS REVEALED THAT THE COREWIRE HAD FRACTURED, MAKING THIS A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64548 JAGWIRE¿ STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00556561 15412514

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR