BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRA JAGWIRE GUIDEWIRE

    MDR report key: 1172364 · Received September 19, 2008

    Report

    Report Number
    3005099803-2008-04726
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDE
    PMA / PMN Number
    K942677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AT THE USER FACILITY, AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, GUIDE WIRE PEELING OCCURRED. THE LESION WAS LOCATED IN THE COMMON BILE DUCT (CBD). AN UNSPECIFIED CANNULA WAS PLACED IN THE CBD. THE 0.035 HYDRA-JAG GUIDE WIRE WAS ADVANCED THROUGH THE CANNULA TO THE LESION. UPON ATTEMPTING TO REMOVE THE CANNULA, THE CANNULA WAS UNABLE TO BE REMOVED AND THE PHYSICIAN NOTED THAT THE MID-PORTION OF THE GUIDE WIRE WHICH REMAINED EXTERIOR TO THE PATIENT CONTAINED PEELED COATING. THE GUIDE WIRE AND CANNULA WERE REMOVED AS A UNIT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRA JAGWIRE GUIDEWIRE FDE BOSTON SCIENTIFIC M00556071

    Patients

    Seq Age Sex Outcome Treatment
    1