BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1080372 · Received July 22, 2008

    Report

    Report Number
    2953144-2008-01223
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 23, 2008
    Report Date
    July 2, 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. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFO. DEVICE #1 PERCLOSE A-T, PART# 12337-06, LOT# 61160-6H, IS BEING FILED UNDER MEDWATCH MFR REPORT NUMBER: 2953144-2008-01222.

    Description of Event or Problem · 1

    DEVICE #2 MALFUNCTION: CUFF MISS, RESISTANCE DURING REMOVAL, FOOT 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 PERCLOSE A-T DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED AND RESISTANCE WAS FELT DURING REMOVAL OF THE DEVICE. THE DEVICE WAS REMOVED AND A SECOND PERCLOSE A-T WAS USED WITH THE SAME RESULTS. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. VISUAL INSPECTION REVEALED THAT A FOOT BREAK OCCURRED WITH BOTH DEVICES. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, 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 61160-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DEVICE #1 PERCLOSE A-T| LOT# 61160-6H