BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3190426 · Received June 26, 2013

    Report

    Report Number
    2134265-2013-04535
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BALLOON ANGIOPLASTY TREATMENT PROCEDURE, BALLOON BURST OCCURRED. THE PATIENT WAS UNDERGOING HEMODIALYSIS ACCESS MANAGEMENT. THE TARGET LESION WAS LOCATED IN THE CALCIFIED ARTERIOVENOUS FISTULA (AVF) SHUNT. THE PHYSICIAN DEPLOYED A 5.0 X 40, 75 CM MUSTANG BALLOON CATHETER TO ENLARGE THE LUMEN. IT WAS NOTED THAT THE BALLOON WAS NOT PROPERLY INFLATED AT ITS NOMINAL PRESSURE POSSIBLY DUE TO THICK CALCIFICATION AND THAT THE BALLOON BURST ON AN UNSPECIFIED INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291212 MUSTANG? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171050470 15879657

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR