BEUDAMED
    FDA Adverse Event Death Summary report: N

    JAGWIRE?

    MDR report key: 4277355 · Received November 25, 2014

    Report

    Report Number
    3005099803-2014-03815
    Event Type
    Death
    Date Received
    November 25, 2014
    Date of Event
    October 24, 2014
    Report Date
    November 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2014-03802 ADDRESSES THE ULTRATOME XL, WHILE MANUFACTURER REPORT # 3005099803-2014-03803 ADDRESSES THE EXTRACTOR BALLOON, AND MANUFACTURER REPORT # 3005099803-2014-03815 ADDRESSES THE JAGWIRE GUIDEWIRE. BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THIS EVENT FROM A TELEVISION MEDIA REPORT ON (B)(6) 2014. IT WAS REPORTED THAT AN EXTRACTOR RETRIEVAL BALLOON, AN ULTRATOME XL, AND A JAGWIRE GUIDEWIRE WERE USED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A BILIARY STONE REMOVAL WAS PERFORMED AND COMPLETED USING THESE DEVICES WITH NO REPORTED MALFUNCTIONS. FOLLOWING THE ERCP PROCEDURE, THE PATIENT FELT PAIN. ¿BASED ON THE MEDIA REPORT, THE PATIENT WENT TO SURGERY POST ERCP FOLLOWED BY AN INFECTION.¿ ON (B)(6), 2014 THE PATIENT DIED. IT WAS REPORTED THAT THE PATIENT HAD NO COMORBIDITIES THAT MAY HAVE CONTRIBUTED TO THE DEATH. THE CAUSE OF DEATH IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765836 JAGWIRE? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00556581 16912868

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death