BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2912007 · Received January 11, 2013

    Report

    Report Number
    2024168-2013-00260
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 24, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. GUIDE WIRE: 0.035-INCH TERUMO, SHEATH: 6-FRENCH TERUMO, HEPARIN.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SUTURE RETRIEVAL ISSUE WAS NOT CONFIRMED AS ANALYSIS OF THE DEVICE REVEALED THAT THE ANTERIOR AND POSTERIOR NEEDLES WERE CAPTURED BY THEIR RESPECTIVE CUFFS AND THE LINK HAD BROKEN FROM THE SWAGE-END OF THE POSTERIOR CUFF, WHICH CAN APPEAR VERY SIMILAR TO THE REPORTED SUTURE RETRIEVAL ISSUE. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PERCUTANEOUS CORONARY INTERVENTION OF THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY, ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, THE PUNCTURE SITE WAS LOCATED BELOW THE INFERIOR EPIGASTRIC ARTERY AND ABOVE THE BIFURCATION. AFTER THE 0.035 INCH GUIDE WIRE WAS REMOVED, THE PROGLIDE DEVICE WAS INSERTED INTO THE VESSEL UNTIL THE MARKER PORT OF THE DEVICE INDICATED PULSATILE (BLOOD) FLOW FROM THE MARKER LUMEN. WHEN THE NEEDLE PLUNGER OF THE DEVICE WAS RETRACTED FROM THE PROGLIDE DEVICE, NO SUTURE WAS PRESENT ONLY THE LINK INDICATING A POSTERIOR NEEDLE-TO-CUFF MISS OCCURRED. A 0.035 INCH GUIDE WIRE WAS RE-INSERTED AND THE PROGLIDE DEVICE WAS REMOVED. THE PROCEDURE WAS PERFORMED UNDER LOCAL ANESTHESIA. A 6-FRENCH SHEATH WAS INSERTED AND WAS REMOVED SIX HOURS AFTER THE PROCEDURE. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO COMPLICATION. 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
    17410 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20406J1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention