BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2933048 · Received January 29, 2013

    Report

    Report Number
    2134265-2013-00184
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RETURNED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE, A BREAK OCCURRED. THE HEAVILY CALCIFIED TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE AT AN UNSPECIFIED TIME, A 4.0 X 150, 135CM MUSTANG¿ BALLOON CATHETER "HIT CALCIUM AND BROKE" IN THE LEFT SFA. THE DEVICE WAS REMOVED AND THE PHYSICIAN "WENT IN WITH A 60 BALLOON LENGTH AND WAS SUCCESSFUL." NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS OK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39199 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171041510 0015379771

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR