BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1220475 · Received November 4, 2008

    Report

    Report Number
    2953144-2008-01771
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 16, 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
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SUTURE RETRIEVAL. TIME OF DEVICE 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 AN UNSPECIFIED VESSEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS PULLED BACK NO SUTURES WERE PRESENT. THE DEVICE WAS REMOVED THE HEMOSTASIS WAS ACHIEVED BY AN UNSPECIFIED METHOD. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    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 68015-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention