BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 6825586 · Received August 28, 2017

    Report

    Report Number
    2134265-2017-08569
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 10, 2017
    Report Date
    August 10, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K110122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOUND THAT ALL DEVICES SHIPPED FROM THE BATCH CONFORMED TO THE PREVENTIVE MEASURES / CURRENT CONTROLS AS PER THE PRODUCT SPECIFICATION. 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 BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA CONTRALATERAL APPROACH. THE 99% IN-STENT RESTENOSED TARGET LESION OF THE PREVIOUSLY DEPLOYED NON-BSC STENT WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). AFTER A GUIDEWIRE WAS ADVANCED, A 7.0 X 150, 135 CM MUSTANG¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED DURING INFLATION. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604092 MUSTANG¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171071510 20061734

    Patients

    Seq Age Sex Outcome Treatment
    1