BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1133185 · Received August 22, 2008

    Report

    Report Number
    2953144-2008-01370
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROGLUDE DEVICE #1, LOT #65186-6H, IS BEING FILED UNDER MEDWATCH MDR #2853144-2008-01369. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE #2 CUFF MISS. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A SUTURE BREAK WAS EXPERIENCED. A SECOND DEVICE WAS USED AND A CUFF MISS WAS EXPERIENCED. HEMOSTASIS WAS ACHIEVED USING A THIRD PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 65186-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DEVICE #1: PROGLIDE