BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDEV TECHNOLOGIES, INC.

    MDR report key: 2341644 · Received November 10, 2011

    Report

    Report Number
    MW5023103
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Date of Event
    November 9, 2011
    Report Date
    November 10, 2011
    Manufacturer
    IDEV TECHNOLOGIES
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HERE FOR ASSESSMENT OF VASCULATURE OF LEFT LEG AND TO DO A LEFT SFA RECANNULATION TO REGAIN BLOODFLOW TO THE LIMB. DURING THE PROCEDURE MULTIPLE STENTS WERE PLACED IN THE SFA. WHILE ATTEMPTING REGAINED BLOODFLOW MET RESISTANCE WHEN INTRODUCING THE ANGIOGRAPHIC CATHETER. IT WAS NOTED THAT THERE WAS A FOREIGN BODY IN THE VESSEL. THE OPERATING PHYSICIAN ATTEMPTED TO RETRIEVE THE DEVICE WITHOUT SUCCESS. IT WAS DETERMINED AFTER SPEAKING WITH THE VASCULAR SURGERY TEAM THAT NO FURTHER RETRIEVAL ATTEMPTS WOULD BE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDEV TECHNOLOGIES, INC. SUPERA VERITAS FGE IDEV TECHNOLOGIES S-05-080-120-G3 01100036

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other