BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPHIRION DEEP PTA BALLOON CATHETER

    MDR report key: 4971076 · Received August 5, 2015

    Report

    Report Number
    3004066202-2015-00363
    Event Type
    Death
    Date Received
    August 5, 2015
    Date of Event
    September 1, 2014
    Report Date
    July 15, 2015
    Manufacturer
    INVATEC SPA
    Product Code
    DQY
    PMA / PMN Number
    K052791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED TWO AMPHIRION DEEP PTA BALLOON CATHETERS IN THE RIGHT PTA ARTERY. APPROXIMATELY 13 MONTHS LATER IT WAS REPORTED THAT THE PATIENT SUFFERED FROM SEPSIS AND THE OUTCOME WAS REPORTED AS DEATH ON THE SAME DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513018 AMPHIRION DEEP PTA BALLOON CATHETER CATHETER, PERCUTANEOUS DQY INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Death