BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1034721 · Received April 24, 2008

    Report

    Report Number
    2953144-2008-00788
    Event Type
    Injury
    Date Received
    April 24, 2008
    Report Date
    March 31, 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. DEVICE #1 PERCLOSE A-T, PART # 12337-05, LOT #61222-6H IS BEING FILED UNDER MEDWATCH MANUFACTURER REPORT NUMBER: 2953144-2008-00787.

    Description of Event or Problem · 1

    DEVICE #2 MALFUNCTION: SUTURE BREAK, KNOT ADVANCEMENT ISSUES. 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 PERCLOSE A-T DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AS THE KNOT WAS BEING ADVANCED TO THE ARTERIAL SURFACE, DIFFICULTY WAS ENCOUNTERED AND THE SUTURE BROKE. THE CLOSURE DEVICE WAS REMOVED AND A SECOND PERCLOSE A-T WAS ATTEMPTED WITH THE SAME RESULTS. A THIRD PERCLOSE A-T WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR-REDWOOD CITY NA 61222-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DEVICE #1 PERCLOSE A-T| LOT #61222-6H