BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2935874 · Received January 30, 2013

    Report

    Report Number
    2134265-2013-00193
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K875064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A GAUGE ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER LEFT EXTREMITY. A ENCORE 26 INFLATION DEVICE WAS USED TO INFLATE A 5X40MM MUSTANG BALLOON CATHETER. HOWEVER, DURING THE FIRST INFLATION ATTEMPT THE DIAL ON THE ENCORE 26 WOULD NOT REGISTER ANY PRESSURE WITH VISUAL CONFIRMATION OF BALLOON INFLATION. THE ENCORE 26 WAS DETACHED AND REPLACED WITH ANOTHER OF THE SAME DEVICE. THE SAME MUSTANG BALLOON CATHETER WAS SUCCESSFULLY USED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41454 ENCORE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK M001151050 15582514

    Patients

    Seq Age Sex Outcome Treatment
    1