BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPHIRION DEEP

    MDR report key: 2801167 · Received October 23, 2012

    Report

    Report Number
    3004066202-2012-00123
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 5, 2012
    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). RESULTS: INHERENT RISK OF THE PROCEDURE (REVASCULARIZATION).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE PHYSICIAN USED TWO AMPHIRION DEEP PTA BALLOON FOR THE TREATMENT OF THE ANTERIOR TIBIAL ARTERY OF THE LEFT LEG. IT WAS REPORTED THAT THE NEXT DAY, AMPUTATION OF DIGIT IV RIGHT WAS REQUIRED DUE TO WORSENING OF GANGRENE. IT WAS REPORTED THAT APPROXIMATELY 12 MONTHS POST INDEX PROCEDURE, RE-STENOSIS OF THE ANTERIOR TIBIAL ARTERY WAS CONFIRMED. REVASCULARIZATION WAS PERFORMED WITH AN AMPHIRION DEEP PTA BALLOON. INVESTIGATOR REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. PATIENT IS REPORTED TO BE RECOVERED AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPHIRION DEEP CATHETER, PERCUTANEOUS DQY INVATEC SPA 1B030281

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention ASA, CLOPIDOGREL