BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3894477 · Received June 25, 2014

    Report

    Report Number
    2134265-2014-03486
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 27, 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. (B)(4). THE COMPLAINT 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. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED UNSPECIFIED VESSEL. A 5.0 X 40, 75CM MUSTANG¿ BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. THE DEVICE WAS SUCCESSFULLY USED SEVERAL TIMES TO DILATE THE LESION BUT AFTER INSERTING IT INTO THE BODY AGAIN, THE PHYSICIAN ATTEMPTED TO INFLATE IT BUT FAILED. THE BALLOON WAS NOTICED TO BE RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371765 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171050470 16727182

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: MOSQUITO 5F| INFLATION DEVICE: ENCORE 26