BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1063442 · Received June 20, 2008

    Report

    Report Number
    2953144-2008-01069
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 29, 2008
    Report Date
    May 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
    GM
    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: FOOT AND NEEDLE BREAK. 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 THE FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A FOOT AND NEEDLE BREAK OCCURRED. THE PHYSICIAN SUSPECTS THAT THE BROKEN PIECES REMAIN IN THE PATIENT'S ANATOMY; HOWEVER, THIS IS UNCONFIRMED. THE PATIENT HAS BEEN MONITORED AND IS REPORTED TO BE DOING FINE. HEMOSTASIS WAS ACHIEVED USING AN ANGIO-SEAL. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 MGB ABBOTT VASCULAR REDWOOD CITY NA 64053-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention HEPARIN