BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 4240972 · Received November 10, 2014

    Report

    Report Number
    2134265-2014-06757
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    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. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA LEFT FEMORAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT COMMON TO EXTERNAL ILIAC ARTERY. AFTER A 9-40 NON BSC GUIDEWIRE CROSSED THE LESION, A 7.0 X 40, 135CM MUSTANG¿ BALLOON CATHETER WAS ADVANCED TO THE LESION. THE BALLOON WAS INFLATED HOWEVER IT RUPTURED AT 5 ATMOSPHERES ON THE FIRST INFLATION. LEAKAGE OF CONTRAST MEDIA WAS CONFIRMED UNDER ANGIOGRAPHY. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. IT WAS CHECKED AND WAS CONFIRMED THAT THE BALLOON RUPTURE LONGITUDINALLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722456 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171070410 17198581

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: DESTINATION 50CM| GUIDEWIRE: ASTATOXS9-40