BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2003267 · Received February 28, 2011

    Report

    Report Number
    2024168-2011-01250
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. OPERATOR NOT TRAINED THE PERCLOSE PROGLIDE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN NOT TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE USING A PRECLOSE TECHNIQUE IN A HEAVILY CALCIFIED FEMORAL ARTERY BEFORE AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING DEPLOYMENT, A CUFF MISS OCCURRED. ANOTHER PROGLIDE WAS USED WITH THE SAME RESULTS. TWO ADDITIONAL PROGLIDES WERE SUCCESSFULLY DEPLOYED AND USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention