BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1884472 · Received October 19, 2010

    Report

    Report Number
    2953144-2010-02534
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PERCLOSE PROGLIDE (PART 12673-03, LOT 920416H) INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. (B)(4) PATIENT SELECTION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN, TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE CONSIDERABLY CALCIFIED COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AN ANTERIOR CUFF MISS OCCURRED. THE DEVICE WAS REMOVED AND ANOTHER PROGLIDE WAS USED WITH THE SAME RESULTS. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 920416H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PERCLOSE PROGLIDE (PART 12673-03, LOT 920416H)