BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1920280 · Received December 10, 2010

    Report

    Report Number
    2953144-2010-03187
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 17, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED;THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.THE SECOND PERCLOSE PROGLIDE 12673-03/UNK IS BEING FILED UNDER A SEPARATE MEDWATCH MFR#.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, DURING KNOT ADVANCEMENT, THE SUTURE BROKE. THE DEVICE WAS REMOVED FROM THE ANATOMY. ANOTHER PROGLIDE DEVICE AND MANUAL COMPRESSION WERE USED TO ACHIEVE HEMOSTASIS. WHILE IN RECOVERY, IT WAS OBSERVED THAT THE PATIENT HAD NO DOPPLER READING. AFTER AN ANGIOGRAM READING, IT WAS REPORTED THAT AN OCCLUSION OCCURRED AT THE SITE AND SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 Required Intervention #2 PERCLOSE PROGLIDE 12673-03/UNK