BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2033044 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02148
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE OTHER PROGLIDE REFERENCED IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, ALL DEPLOYMENT STEPS WERE COMPLETED UNEVENTFULLY, HOWEVER, BLEEDING WAS STILL OBSERVED COMING OUT OF THE PATIENT'S GROIN. THE DEVICE WAS REMOVED, THE TECHNICIAN ATTEMPTED VESSEL CLOSURE WITH ANOTHER PROGLIDE; HOWEVER, THE SAME ISSUE OCCURRED. THIS SECOND DEVICE WAS ALSO REMOVED FROM THE PATIENT'S ANATOMY AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS 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 42 YR Required Intervention