BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGER¿

    MDR report key: 2970431 · Received February 20, 2013

    Report

    Report Number
    2134265-2013-00776
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K110122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. FROM THE INFORMATION AVAILABLE THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE BALLOON RUPTURED AFTER THE BALLOON WAS INFLATED ABOVE ITS RATED BURST PRESSURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FISTULOGRAM TREATMENT PROCEDURE, A BALLOON BURST OCCURRED. THE LESION WAS LOCATED IN THE AV FISTULA OF THE BASILIC VEIN. THE 7.0 X 40 MM CHARGER BALLOON CATHETER WAS ADVANCED INSIDE A NON-BSC STENT. THE CHARGER BALLOON WAS INFLATED ONCE OVER RATED BURST PRESSURE AND BURST CIRCUMFERENTIALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74686 CHARGER¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939206070470 15674391

    Patients

    Seq Age Sex Outcome Treatment
    1