BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLADIATOR¿

    MDR report key: 2479323 · Received March 6, 2012

    Report

    Report Number
    2134265-2012-00925
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    February 6, 2012
    Report Date
    February 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA# OR 510K# : K113681. 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 AN ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESSED WAS GAINED VIA THE ARM. THE TARGET LESION WAS LOCATED IN A MILDLY CALCIFIED DIALYSIS FISTULA LOCATED IN THE ARM. A NON BSC GUIDE WIRE AND AN UNKNOWN 6FR SHEATH WERE USED WITH A GLADIATOR 10.0 X40, 75CM BALLOON CATHETER. THE BALLOON WAS INFLATED TO 15 ATMS AND RUPTURED. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A NON BSC BALLOON CATHETER USING THE SAME SHEATH AND GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLADIATOR¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939207100470

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: ROAD RUNNER