BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2820370 · Received November 6, 2012

    Report

    Report Number
    2024168-2012-06967
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 OTHER TWO PERCLOSE PROGLIDE DEVICES ARE BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBERS. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLACEMENT OF THE PROGLIDE SUTURES WAS ATTEMPTED IN THE RIGHT AND LEFT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE BEFORE AN INTERVENTIONAL PROCEDURE. REPORTEDLY, ON THE RIGHT GROIN, THE FIRST PROGLIDE WAS DEPLOYED NO SUTURES WERE SEEN UPON REMOVING PLUNGER. THE SECOND PROGLIDE WAS INSERTED AND UPON PLUNGER REMOVAL NO SUTURES WERE PRESENT. A THIRD PROGLIDE WAS SUCCESSFULLY USED. ON THE LEFT GROIN THE FIRST PROGLIDE WAS DEPLOYED AND UPON PLUNGER REMOVAL NO SUTURES WERE PRESENT. A SECOND AND THIRD PROGLIDE WERE SUCCESSFULLY USED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. 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 Required Intervention SHEATH: 7FR, 20FRHEPARIN