BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADMIRAL XTREME

    MDR report key: 2860961 · Received December 6, 2012

    Report

    Report Number
    3004066202-2012-00147
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    December 10, 2009
    Report Date
    November 22, 2012
    Manufacturer
    INVATEC SPA
    Product Code
    LIT
    PMA / PMN Number
    K103464
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (PERFORATION).

    Description of Event or Problem · 1

    AN ADMIRAL XTREME PTA BALLOON CATHETER WAS USED TO TREAT THE POPLITEAL ARTERY IN THE RIGHT LEG. DURING THE PROCEDURE A PERFORATION OCCURRED AND WAS TREATED WITH POBA. INVESTIGATOR REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention