BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 4191951 · Received October 22, 2014

    Report

    Report Number
    2134265-2014-06415
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K110122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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. AN 8.0 X 40, 75CM MUSTANG¿ PTA BALLOON DILATATION CATHETER WAS SELECTED FOR USE TO PREDILATE THE UNSPECIFIED TARGET LESION. HOWEVER, THE BALLOON RUPTURED AS IT REACHED ITS NOMINAL PRESSURE WITH NO APPARENT REASON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. THE 8.0 X 40, 75CM MUSTANG¿ BALLOON WAS INITIALLY INFLATED AT 10 ATMOSPHERES FOR A DURATION OF 30 SECONDS. UPON THE SECOND INFLATION, THE BALLOON RUPTURED AT 10 ATMOSPHERES STILL ON THE SAME DURATION. THE DEVICE WAS COMPLETELY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672866 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171080470 17016278

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR