BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2863738 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07789
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED NEEDLE-TO-CUFF MISS WAS CONFIRMED AS ANALYSIS OF THE DEVICE INDICATED AN ANTERIOR CUFF NEEDLE-TO-CUFF MISS OCCURRED AS EVIDENCED BY THE RETURN OF THE ANTERIOR CUFF LOOSE WITH THE CUFF TABS IN PRE-DEPLOYED POSITIONS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET 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 MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PERCUTANEOUS CAROTID INTERVENTIONAL PROCEDURE, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED, NO SUTURE WAS PRESENT. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS ATTEMPTED, BUT WITH THE SAME RESULTS; A NEEDLE-TO-CUFF MISS OCCURRED. A THIRD PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. 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
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20821J1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SHEATH: 6-FRENCH. ANGIOMAX