BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPHIRION DEEP

    MDR report key: 3091916 · Received May 3, 2013

    Report

    Report Number
    3004066202-2013-00072
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    June 17, 2011
    Report Date
    April 12, 2013
    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

    REVASCULARIZATION. (B)(4).

    Description of Event or Problem · 1

    DURING AN INDEX PROCEDURE, IT WAS REPORTED THAT A PHYSICIAN USED ONE AMPHIPRION DEEP PTA BALLOON CATHETER FOR TREATMENT OF THE POSTERIOR TIBIAL ARTERY OF THE RIGHT LEG OF A PATIENT. APPROXIMATELY 5.5 MONTHS POST THE INDEX PROCEDURE, THE PATIENT UNDERWENT TARGET LESION REVASCULARISATION AND A FALCON BALLOON CATHETER WAS USED AS TREATMENT. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS UNLIKELY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE STUDY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194190 AMPHIRION DEEP CATHETER, PERCUTANEOUS DQY INVATEC SPA 1B020668

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention