BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1812556 · Received August 16, 2010

    Report

    Report Number
    2953144-2010-01647
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 22, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE #2 AND #3: PART #12673-03, LOT #90002-6H, 90005-6H INDICATED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE DEVICE WAS RECEIVED, INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE #1 ISSUE: NEEDLE-TO-CUFF MISS. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED, A NEEDLE WAS NOT CAPTURED BY THE CUFF. THE DEVICE WAS REMOVED. TWO ADDITIONAL PROGLIDE DEVICES WERE ATTEMPTED WITH THE SAME RESULTS. THE METHOD OF HOW HEMOSTASIS WAS ACHIEVED WAS NOT REPORTED. THERE WERE NO REPORTED PATIENT ADVERSE EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 90015-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention PART #12673-03, LOT #90002-6H| DEVICE #2: PROGLIDE| DEVICE #3: PROGLIDE| LOT #90005-6H