BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 3865564 · Received June 2, 2014

    Report

    Report Number
    3865564
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2013
    Report Date
    June 2, 2014
    Manufacturer
    ABBOTT VASCULAR, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD LEFT HEART CATHETERIZATION WITH SELECTIVE CORONARY ANGIOGRAM. LEFT VENTRICULOGRAM WAS PERFORMED. RIGHT COMMON FEMORAL ANGIOGRAM WAS PERFORMED WITH ATTEMPTED CLOSURE WITH ABBOTT VASCULAR PERCLOSE PROGLIDE DEVICE. THE PERCLOSE SUTURE BROKE, SO MANUAL PRESSURE WAS USED. THE PATIENT TOLERATED THE PROCEDURE VERY WELL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322038 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR