BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3250804 · Received July 29, 2013

    Report

    Report Number
    2024168-2013-04717
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 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
    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. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICE, REFERENCED WAS FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A CORONARY VALVULOPLASTY PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED IN A MILDLY SCARRED RIGHT COMMON FEMORAL ARTERY USING PERCLOSE PROGLIDE DEVICES. REPORTEDLY, DURING DEPLOYMENT OF THE INITIAL TWO PROGLIDE DEVICES THROUGH A 12-FRENCH SIZED ACCESS SITE, BOTH INCURRED A NEEDLE-TO-CUFF MISS. BOTH PROGLIDE DEVICES WERE REMOVED AND THE SUTURE FROM TWO ADDITIONAL PROGLIDE DEVICES WERE SUCCESSFULLY DEPLOYED AND SET TO THE SIDE. AFTER CONCLUSION OF THE CORONARY VALVULOPLASTY PROCEDURE, THE KNOTS FROM THE TWO PROGLIDE DEVICES WERE SEQUENTIALLY ADVANCED AND TIGHTENED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. 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
    352863 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30409K1

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention SHEATH: 12-FRENCH HEPARIN