BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRU-INCISE VALVULOTOME

    MDR report key: 3779531 · Received April 28, 2014

    Report

    Report Number
    3779531
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 28, 2014
    Manufacturer
    URESIL, LLC
    Product Code
    MGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    URESIL TRU-INCISE VALVULOTOME DID NOT WORK PROPERLY IN SURGICAL PROCEDURE. WHEN INJECTING HEPARINIZED SALINE THROUGH THE CATHETER TO PRIME FOR PROCEDURE, SALINE WAS LEAKING/SPURTING THROUGH THE AREA WHERE INJECTION SITE/JUNCTION MEETS CATHETER. DEVICE MOVED TO BACK TABLE AND NOT USED ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253905 TRU-INCISE VALVULOTOME VALVULOTOME MGZ URESIL, LLC * 3G680

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR INJECTION WITH HEPARINIZED SALINE