BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3083180 · Received April 29, 2013

    Report

    Report Number
    2024168-2013-02659
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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. ESTIMATED DATE OF OCCURRENCE, EXACT DATE COULD NOT BE REMEMBERED. THE OTHER TWO PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. EVALUATION SUMMARY: THE BODY OF THE DEVICE BODY WAS RETURNED FOR EVALUATION. THE PLUNGER, CUFFS, LINK, NEEDLE TIP AND MONOFILAMENT WERE NOT RETURNED WITH THE DEVICE; THEREFORE, THE SCOPE OF THIS INVESTIGATION WAS VERY LIMITED AND THE REPORTED EXPERIENCE COULD NOT BE CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE COMPONENTS, 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 AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6F SHEATH AFTER A PERIPHERAL STENTING PROCEDURE. REPORTEDLY, AFTER INDEX PROCEDURE THE KNOT WOULD NOT ADVANCE TO THE ARTERY. THE TECHNICIAN ATTEMPTED TO ADVANCE THE KNOT THREE TIMES, THEN REMOVED THE SUTURE. A SECOND AND THIRD PROGLIDE DEVICES WERE ATTEMPTED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING MANUAL ARTERIAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE TECHNICIAN IS REPORTED TO BE IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE. THE PHYSICIAN PROCTOR AND ATTENDING PHYSICIAN, WHO WERE BOTH IN ATTENDANCE ARE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185432 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30215K1

    Patients

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