BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1293084 · Received January 22, 2009

    Report

    Report Number
    2953144-2009-00075
    Event Type
    Injury
    Date Received
    January 22, 2009
    Date of Event
    January 9, 2009
    Report Date
    January 13, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. DEVICE #1- PERCLOSE AT (PART #12337-05; LOT #70035-6H) AND DEVICE #2- PERCLOSE AT (PART #12337-05; LOT #70017-6H), ARE BEING FILED UNDER MEDWATCH REPORT #2953144-2009-00072 (DEVICE #1) AND MEDWATCH REPORT #2953144-2009-00074 (DEVICE #2).

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SUTURE RETRIEVAL (DEVICE #3). TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE AT DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS PULLED BACK THERE WAS NO SUTURE PRESENT. THE DEVICE WAS REMOVED AND A SECOND AND THIRD PERCLOSE AT WERE USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING A FOURTH PERCLOSE AT DEVICE. THE ACCESS SITE WAS IN A VASCULAR GRAFT. 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 70017-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention VESSEL CLOSURE: DEVICE #1-PERCLOSE (PART# 12337-05| LOT #70035-6H)| DEVICE #2-PERCLOSE (PART# 12337-05