BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 1883474 · Received October 19, 2010

    Report

    Report Number
    1883474
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELDERLY PATIENT UNDERWENT CATHETERIZATION AND ANGIOGRAPHY OF HIS PERONEAL ARTERY VIA FEMORAL PUNCTURE. AT THE CONCLUSION OF THE PROCEDURE, TWO ATTEMPTS WERE MADE TO CLOSE THE WOUND WITH A 6-FRENCH PERCLOSE DEVICE. THE SUTURE FAILED TO DEPLOY ON BOTH OCCASIONS.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE DEVICE FAILED TO DEPLOY THE CLOSURE SUTURE TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT LABORATORIES * *
    2 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT LABORATORIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR NO OTHER THERAPIES