BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEFLEX BALLOON 6.0 X 200 MM OTW

    MDR report key: 2541231 · Received April 13, 2012

    Report

    Report Number
    MW5025065
    Event Type
    Injury
    Date Received
    April 13, 2012
    Date of Event
    April 11, 2012
    Report Date
    April 13, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IDEV GLIDERFLEX BALLOON 6 X 200 MM WAS PLACED IN RIGHT SFA AND INFLATED. THE BALLOON DID NOT DEFLATE AND AFTER SEVERAL DEFLATION TECHNIQUES A 18 G NEEDLE WAS USED TO PUNCTURE BALLOON VIA PERCUTANEOUS STICK OF ARTERY. THE BALLOON WAS DEFLATED AND NEEDLE REMOVED WITH EXTERNAL PRESSURE HELD FOR HEMOSTASIS. NO HARM WAS DONE TO PT AND BALLOON CATHETER REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIDEFLEX BALLOON 6.0 X 200 MM OTW BALLOON LIT IDEV TECHNOLOGIES, INC. FC110921015

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Disability