BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3770929 · Received April 24, 2014

    Report

    Report Number
    2134265-2014-02072
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    March 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K110122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RECEIVED WITH A 0.035INCH WIRE INSERTED THROUGH THE WIRE LUMEN. THE GUIDEWIRE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. NO DAMAGE WAS NOTED ALONG THE LENGTH OF THE DEVICE. AN ATTEMPT TO REMOVE THE WIRE FAILED. AS A RESULT THE DEVICE AND WIRE WERE DISSECTED AT 37.3CM DISTAL TO THE STRAIN RELIEF. ONCE THIS DISSECTION WAS MADE, BOTH SECTIONS OF THE WIRE WERE REMOVED FROM BOTH SECTIONS OF THE DISSECTED DEVICE. A LARGE BUILD-UP OF SOLIDIFIED BLOOD WAS PRESENT ON THE WIRE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    THIS DEVICE WAS RECEIVED WITH NO REPORTED ISSUES.  HOWEVER, UPON REVIEW OF THIS DEVICE, CATHETER ENTRAPMENT WAS FOUND.  A 9.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS SELECTED TO DILATE THE TARGET LESION. AN UNKNOWN GUIDE WIRE WAS STUCK ON THE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248654 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171090470 16340178

    Patients

    Seq Age Sex Outcome Treatment
    1