BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1202876 · Received October 17, 2008

    Report

    Report Number
    2953144-2008-01702
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A F/U WILL BE SUBMITTED WITH ANY RELEVANT INFO. DEVICES #1, #2 AND #3 - PERCLOSE AT (PART# 12337-05; LOT #49058-6H), ARE BEING FILED UNDER MEDWATCH REPORTS 2953144-2008-01699, -01700 AND -01701, RESPECTIVELY.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SUTURE RETRIEVAL (DEVICE #4). TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL, USING A PERCLOSE AT DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, UPON WITHDRAWAL OF THE PLUNGER THERE WAS NO SUTURE PRESENT. THE DEVICE WAS REMOVED AND THREE PERCLOSE AT DEVICES WERE USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED, USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    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 49058-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention VESSEL CLOSURE: DEVICES #1| AT (PART# 12337-05, LOT# 49058-6H)