BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1584364 · Received January 19, 2010

    Report

    Report Number
    2953144-2010-00097
    Event Type
    Injury
    Date Received
    January 19, 2010
    Date of Event
    November 23, 2009
    Report Date
    January 7, 2010
    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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE#1: PART# 12673-03, LOT# 82021-6H INDICATED IS BEING FILED UNDER MEDWATCH MFR NUMBER 2953144-2010-00095. DEVICE#2: 12673-03, LOT# 82021-6H INDICATED IS BEING FILED UNDER MEDWATCH MFR NUMBER 2953144-2010-00096. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE #3 CUFF MISS. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PT EFFECTS REPORTED. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 82021-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT#82021-6H| DEVICE #1 AND #2, PROGLIDE PART# 12673-03