BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL VIP

    MDR report key: 3042081 · Received April 5, 2013

    Report

    Report Number
    3042081
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO WITHDRAW THE DEPLOYMENT SYSTEM FROM THE BODY (PATIENT'S), THE SHEATH WOULD NOT WITHDRAW. MULTIPLE ATTEMPTS WERE MADE BY TWO DIFFERENT CARDIOLOGISTS TO REMOVE SHEATH. VASCULAR CALLED AND PATIENT TAKEN TO SURGERY FOR A GROIN CUTDOWN TO REMOVE SHEATH. UPON ARRIVAL AND DRAPING IN SURGERY THE VASCULAR SURGEON WAS ABLE TO REMOVE SHEATH WITHOUT THE NEED FOR SURGERY.MANUFACTURER RESPONSE FOR ANGIO-SEAL VASCULAR CLOSURE DEVICE, ANGIO-SEAL VASCULAR CLOSURE DEVICE (PER SITE REPORTER).MANUFACTURER'S REPRESENTATIVE CALLED AND ADVISED OF PROBLEM. SUGGESTION MADE THAT POSSIBLY THE WHEEL WITHIN THE DISTAL PORTION OF THE DEVICE WAS STUCK.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CARDIAC CATHERIZATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141014 ANGIO-SEAL VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL * 3904299

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR CARDIAC DRUGS