BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGER¿

    MDR report key: 2871779 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07794
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 18, 2012
    Report Date
    November 27, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K110122
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 A BALLOON RUPTURE OCCURRED. THE LESION WAS LOCATED IN THE ARTEROVENOUS FISTULA GRAM. THE CHARGER 6.0 X 200, 135 CM BALLOON WAS UNABLE TO CROSS THE LESION. THEY PULLED BACK THE BALLOON AND IT WAS NOTED THAT THE BALLOON WAS RUPTURED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARGER¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939206062010 14885603

    Patients

    Seq Age Sex Outcome Treatment
    1