BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1611695 · Received February 18, 2010

    Report

    Report Number
    2953144-2010-00252
    Event Type
    Injury
    Date Received
    February 18, 2010
    Date of Event
    January 11, 2010
    Report Date
    January 27, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) - IMPROPER METHOD-PATIENT SELECTION. DEVICE# 1 PART# 12673-03/LOT# 81033-6H AND DEVICE#2 PART# 12673-03/LOT# 81033-6H INDICATED ARE BEING FILED UNDER MEDWATCH MFR NUMBERS 2953144-2010-00250 AND 2953144-2010-00251. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NEEDLE-TO-CUFF MISS. 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 PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A SCARRED MODERATELY CALCIFIED COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS RETRACTED THE NEEDLE WAS NOT CAPTURED BY THE CUFF. THE DEVICE WAS REMOVED AND A SECOND AND THIRD PROGLIDE WERE USED WITH THE SAME RESULTS. THE DEVICE WAS REMOVED AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. 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 PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 81033-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DEVICE# 2 PROGLIDE PART# 12673-03/LOT#81033-6H| DEVICE# 1 PROGLIDE PART# 12673-03/LOT#81033-6H