BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDICAL CLOSURE (SMC) SYSTEM

    MDR report key: 1234787 · Received November 14, 2008

    Report

    Report Number
    2953144-2008-01843
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 23, 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
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EXPECTED TO BE RETURNED FOR EVALUATION. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION. DEVICE#1 PERCLOSE A-T, LOT# UNK, IS BEING FILED UNDER MEDWATCH MANUFACTURER REPORT NUMBER: 2953144-2008-001842.

    Description of Event or Problem · 1

    DEVICE #2 MALFUNCTION: SUTURE BREAK. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE PERCLOSE A-T DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS RETRACTED, THE SUTURE BROKE. A SECOND PERCLOSE A-T DEVICE WAS ATTEMPTED, BUT RESULTED IN A SUTURE BREAK. THE DEVICE WAS REMOVED AND AN ANGIOSEAL WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DEVICE #1 PERCLOSE A-T