BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3871292 · Received June 13, 2014

    Report

    Report Number
    2024168-2014-03794
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 19, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION SUMMARY: THE SUTURE MEDICATED CLOSURE (SMC) SYSTEM WAS RETURNED FOR ANALYSIS. THE LEVER HAD BEEN CLOSED AND THE FOOT HAD BEEN RETRACTED INTO THE GUIDE. THE SUTURE WAS RETURNED OUTSIDE THE DEVICE AND THE PRE-TIED KNOT WAS FORMED. THE RAIL SUTURE END WAS CUT WITH THE DEVICE CUTTER. THE SUTURE LOOP WAS STILL IN THE SUTURE BEARING. BOTH CUFFS HAD BEEN ENGAGED WITH THE NEEDLES. THE REPORTED NEEDLE TO CUFF MISS COULD NOT BE CONFIRMED. BASED ON VISUAL AND FUNCTIONAL 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. A QUERY OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL PROGLIDE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6FR SHEATH AFTER A NEURO INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. A THIRD PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. 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.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED: THE DEVICES WERE USED IN THE PRECLOSE TECHNIQUE. THE PHYSICIAN IS ESTABLISHED IN THE PRECLOSE TECHNIQUE. USER FACILITY MEDWATCH STATING: EVENT DESC: AT THE CONCLUSION OF AN ANGIOGRAM, TWO DEVICES WERE USED TO ATTEMPT TO CLOSE A FEMORAL ARTERY. NEITHER DEVICE WOULD CLOSE THE ARTERY. ANOTHER DEVICE WAS USED AND THE PATIENT WAS NOT HARMED. THIS FACILITY HAS HAD A TOTAL OF FOUR SIMILAR EVENTS WITH THIS DEVICE. ALL FOUR DEVICES WERE RETURNED TO THE MANUFACTURER. ALL FOUR DEVICES HAD THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350897 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40217K1

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SHEATH: 6FR, TISSUE PLASMINOGEN ACTIVATOR