BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPHIRION DEEP PTA BALLOON CATHETER

    MDR report key: 3212260 · Received July 9, 2013

    Report

    Report Number
    3004066202-2013-00110
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 24, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    DQY
    PMA / PMN Number
    K052791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE ¿ (REVASCULARIZATION). CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (REVASCULARIZATION). (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PHYSICIAN USED ONE AMPHIRION BALLOON TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR TIBIAL ARTERY. APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED RE-OCCLUSION OF THE LEFT ANTERIOR TIBIAL ARTERY WHICH WAS TREATED WITH BY AN UNKNOWN BALLOON TARGET VESSEL REVASCULARIZATION. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. IT IS REPORTED THAT THE EVENT IS UNRESOLVED AND IS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314083 AMPHIRION DEEP PTA BALLOON CATHETER CATHETER, PERCUTANEOUS DQY INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention