BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1078004 · Received July 16, 2008

    Report

    Report Number
    2953144-2008-01189
    Event Type
    Injury
    Date Received
    July 16, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 24, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN RECEIVED. DEVICE #1: PERCLOSE AT, PART #12337-06, LOT #63148-6H, IS BEING FILED UNDER MEDWATCH MFR# 2953144-2008-01188.

    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 TRAINED PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED ARTERY USING THE PERCLOSE AT AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AN ANTERIOR CUFF MISS OCCURRED. THE DEVICE WAS REPLACED WITH A SECOND PERCLOSE AT WHICH HAD THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PT EFFECTS. 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 63148-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DEVICE #1 PERCLOSE AT