BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 5067844 · Received September 10, 2015

    Report

    Report Number
    3004066202-2015-00408
    Event Type
    Death
    Date Received
    September 10, 2015
    Date of Event
    June 4, 2015
    Report Date
    August 12, 2015
    Manufacturer
    INVATEC TECHNOLOGY CENTER GMBH
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN IN.PACT ADMIRAL BALLOON WAS USED TO TREAT THE POPLITEAL ARTERY AND SFA (SAME IN.PACT ADMIRAL DEVICE WAS USED TO TREAT THE SFA AND POPLITEAL). APPROXIMATELY 4 MONTHS LATER THE PATIENT SUFFERED ANEMIA AND GENERAL DETORTATION, THE PATIENT WAS HOSPITALIZED AND EXPIRED APPROXIMATELY 2 MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600741 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU INVATEC TECHNOLOGY CENTER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Death| H