BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADMIRAL XTREME

    MDR report key: 3033191 · Received April 3, 2013

    Report

    Report Number
    3004066202-2013-00039
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 5, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    LIT
    PMA / PMN Number
    K062809
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: NO DEVICE OR CINE IMAGES RETURNED, LIMITED INFORMATION RECEIVED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS WITHDRAWING AN ADMIRAL XTREME DEVICE THROUGH THE SHEATH. IT WAS REPORTED THAT THE BALLOON DETACHED AND WAS STENTED AGAINST THE VESSEL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136653 ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention