BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLADIATOR¿

    MDR report key: 2970345 · Received February 20, 2013

    Report

    Report Number
    2134265-2013-00890
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K113681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (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 INTERVENTION PROCEDURE A BALLOON PINHOLE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FISTULA. THE DENOVO TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED LEFT ARM. A 12.0 X40, 75CM GLADIATOR WAS ADVANCED TO PREDILATE THE TARGET LESION. DURING THE FIRST ATTEMPT TO INFLATE, THE BALLOON WAS UNABLE TO HOLD PRESSURE. IT WAS BELIEVED THAT THERE WAS A PINHOLE IN THE BALLOON. THE GLADIATOR BALLOON CATHETER WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73614 GLADIATOR¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939207120470 15337822

    Patients

    Seq Age Sex Outcome Treatment
    1