BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3873185 · Received June 13, 2014

    Report

    Report Number
    2024168-2014-03841
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROGLIDE DEVICE REPORTED IN THIS INCIDENT WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT WAS NOT PERFORMED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED. IN ADDITION, A QUERY OF THE COMPLAINT DATABASE WAS NOT PERFORMED, BECAUSE THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE OTHER TWO PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS SUCCESSFUL WITH TWO PROGLIDE DEVICES IN A COMMON FEMORAL ARTERY PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. A THIRD PROGLIDE DEVICE WAS BEING DEPLOYED AT THE 12 O'CLOCK POSITION WHEN RETRACTING THE PLUNGER A CUFF MISS OCCURRED. WHEN REMOVING THE THIRD PROGLIDE DEVICE IT APPEARED THAT THE SUTURE HAD WRAPPED/ENTANGLED WITH THE TWO PRE-PLACED PROGLIDE SUTURES. THE SUTURES OF THE FIRST AND SECOND PRE-PLACED PROGLIDE WERE CUT SO TO REMOVE THE THIRD PROGLIDE DEVICE FROM THE ANATOMY. THREE ADDITIONAL PROGLIDE DEVICES WERE SUCCESSFULLY DEPLOYED USING THE PRECLOSE TECHNIQUE. THE ARTERIOTOMY WAS A 6F AND THE SHEATH WAS UPSIZED TO AN 8F AND THEN TO A 22F TO COMPLETE THE AAA PROCEDURE. HEMOSTASIS WAS ACHIEVED USING THE SECOND SET OF THREE PROGLIDE PRE-PLACED SUTURES. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE PRECLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351342 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention SHEATH: 6F, 8F, 22F, HEPARIN