BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1488330 · Received September 30, 2009

    Report

    Report Number
    2953144-2009-01333
    Event Type
    Injury
    Date Received
    September 30, 2009
    Date of Event
    August 20, 2009
    Report Date
    September 10, 2009
    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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CROSS-OVER PROCEDURE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. DEVICE #2 - PERCLOSE A-T (PART #12337-05; LOT #UNK), IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: UNK. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. TIME OF SYMPTOMS/AE: DURING VESSEL CLOSURE. IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED AN ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL USING TWO PERCLOSE A-T DEVICES (CROSS-OVER METHOD) AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE DEVICE DID NOT WORK AND THE DEVICE WAS REMOVED UNEVENTFULLY. THE NICK AND SPREAD INCISION WAS EXTENDED TO REMOVE THE DEVICE AND THE VESSEL WAS SUTURED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. NO ADDITIONAL INFO WAS PROVIDED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention VESSEL CLOSURE: DEVICE #2 - PERCLOSE A-T| (PART #12337-05, LOT # UNK)