BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLADIATOR¿

    MDR report key: 3013434 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01550
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    November 20, 2012
    Report Date
    February 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K113681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 PERIPHERAL TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PHYSICIAN ADVANCED THE GLADIATOR BALLOON CATHETER TO THE TARGET LESION WHERE, AT UNKNOWN ATMS, THE BALLOON RUPTURED CIRCUMFERENTIALLY. A CUT DOWN WAS REQUIRED TO REMOVE THE BALLOON (INCISION). NO OTHER COMPLICATIONS WERE REPORTED. THE LAST INFLATION THAT BROKE THE BALLOON PRODUCED A GOOD RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116230 GLADIATOR¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939207090470

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention