BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1905100 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02951
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.THE FIRST PERCLOSE PROGLIDE (12673-03/UNK), INDICATED IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USED OF THE PERCLOSE PROGLIDE DEVICE DEPLOYED TWO DEVICES USING A PRE-CLOSE TECHNIQUE BEFORE AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. REPORTEDLY, AFTER THE INTERVENTIONAL PROCEDURE, TOO MUCH FORCE WAS USED WHILE PUSHING THE KNOT DOWN, AND THE SUTURE BROKE ON BOTH OF THE DEVICES. HEMOSTASIS WAS ACHIEVED WITH SURGERY. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention