BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE

    MDR report key: 1050131 · Received May 9, 2008

    Report

    Report Number
    1050131
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ABBOTT VASCULAR DEVICES
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DECISION MADE TO PERCLOSE RT FEMORAL ARTERY. MD FOLLOWING DEPLOYMENT INSTRUCTIONS, BUT UPON CUTTING THE SUTURE ON THE DEPLOYMENT NEEDLE, THE KNOT WAS ON TOP OF THE SKIN INSTEAD OF BELOW. THE MD PULLED THE SUTURE AND INSERTED A LARGER FRENCH SHEATH. AN ACT WAS PERFORMED (169), THE SHEATH WAS PULLED AND MANUAL PRESSURE APPLIED TO SITE WITH CHITOSEAL TO PUNCTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE VASCULAR CLOSURE DEVICE MGB ABBOTT VASCULAR DEVICES 12673 62031-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR