BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3083135 · Received April 29, 2013

    Report

    Report Number
    2024168-2013-02656
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE OTHER PERCLOSE PROGLIDE DEVICES WERE FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN INTERVENTIONAL PROCEDURE, BILATERAL ARTERIOTOMY CLOSURE OF THE RIGHT AND LEFT COMMON FEMORAL ARTERIES (RCFA AND LCFA) WAS ATTEMPTED USING PERCLOSE PROGLIDE DEVICES. REPORTEDLY, DURING SUTURE DEPLOYMENT IN THE RCFA, A NEEDLE-TO-CUFF MISS OCCURRED. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS OF THE RCFA. REPORTEDLY, ALTHOUGH THE SUTURE OF TWO PROGLIDE DEVICES WERE SUCCESSFULLY DEPLOYED IN THE LCFA, AFTER THE KNOTS WERE FULLY ADVANCED TO THE VESSEL, BLEEDING CONTINUED. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS ADDING TWENTY MINUTES TO THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183831 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30118J1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention SHEATHS: 7-FRENCH, HEPARIN