BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3193535 · Received June 27, 2013

    Report

    Report Number
    2024168-2013-04031
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS NOT CONFIRMED. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SUTURE LOOP REMAINED IN THE SUTURE BEARING, WHICH WOULD HAVE RESULTED IN THE WHOLE SUTURE CONTAINING THE KNOT BEING REMOVED ALONG WITH THE DEVICE, AND COULD APPEAR SIMILAR TO THE REPORTED SUTURE WITH KNOT COMING OUT OF THE DEVICE. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY USING A PROGLIDE DEVICE WITH A 6F SHEATH AFTER AN INTERVENTIONAL STENTING PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). REPORTEDLY, WHEN THE PLUNGER WAS RETRACTED THE SUTURE WITH KNOT "CAME OUT" OF THE DEVICE. HEMOSTASIS WAS ACHIEVED USING A SECOND PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294390 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21029J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, HEPARIN