BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1910803 · Received November 30, 2010

    Report

    Report Number
    2953144-2010-03029
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE KNOT COULD NOT BE APPLIED AND HEMOSTASIS COULD NOT BE ACHIEVED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED. THOUGH REQUESTED, 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 930126H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN