BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRAJAGWIRE

    MDR report key: 2971926 · Received February 21, 2013

    Report

    Report Number
    3005099803-2013-00800
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 26, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) FOR THE REPORTED EVENT OF GUIDEWIRE DETACHMENT. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6). 2013. ACCORDING TO THE COMPLAINANT, THERE WERE NO ISSUES NOTED DURING THE PROCEDURE AND IT WAS COMPLETED WITH THE JAGWIRE. ON (B)(6) 2013, A CAT SCAN REVEALED SOMETHING IN THE LEFT HEPATIC LOBE WHICH IS SUSPECTED TO BE PART OF THE JAGWIRE, HOWEVER, THAT HAS NOT BEEN CONFIRMED. THERE ARE NO PLANS TO RECOVER THE FRAGMENT AND THE PATIENT IS CURRENTLY BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76402 HYDRAJAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00556000

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR