BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4190913 · Received October 21, 2014

    Report

    Report Number
    2024168-2014-06882
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 29, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED NEEDLE TO CUFF MISS WAS CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURES OF THE RIGHT COMMON FEMORAL ARTERY AND THE LEFT COMMON FEMORAL ARTERY WERE ATTEMPTED WITH PROGLIDE DEVICES, USING A PRE-CLOSE TECHNIQUE, VIA A 8F SHEATH PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. REPORTEDLY, ON BOTH SIDES AFTER THE PLUNGER WAS RETRACTED, NO LINK OR SUTURE PRESENT AT THE NEEDLE TIP. THE SUTURES OF TWO ADDITIONAL PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED ON BOTH SIDE PRIOR TO THE EVAR PROCEDURE. THE SHEATH WAS UPSIZED TO 11F ON ONE SIDE AND 18F ON THE OTHER SIDE AND THE EVAR PROCEDURE WAS COMPLETED. ON BOTH SIDES THE SUCCESSFULLY PRE-PLACED SUTURES OF TWO PROGLIDE DEVICES WERE USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE LARGE HOLE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669009 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40625K1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention 8F, 11F, 18F SHEATHS, .035 GUIDE WIRESPOLOCARD