BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2183017 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05360
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 7, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS WHICH MAY HAVE AIDED IN THE INVESTIGATION. WITHOUT DEVICE ANALYSIS, A CAUSE FOR THE REPORTED RESISTANCE CLOSING THE LEVER COULD NOT BE DETERMINED. RESISTANCE ENCOUNTERED WHILE CLOSING THE LEVER CAN OCCUR DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, USER TECHNIQUE AND PATIENT ANATOMICAL CONDITIONS. EACH DEVICE IS CHECKED FOR THE FUNCTIONALITY OF THE LEVER DURING MANUFACTURING. IN ADDITION, A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD WAS NOT PERFORMED BECAUSE THE DEVICE LOT NUMBER WAS NOT REPORTED AND THE DEVICE WAS NOT RETURNED. BASED ON THE REVIEW OF THE EVENT INFORMATION, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ESTIMATED DATE (REPORTED AS (B)(6) 2011, EXACT DATE NOT AVAILABLE.) THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER SUTURE DEPLOYMENT, WHEN THE LEVER WAS BEING PUSHED DOWN TO CLOSE THE FOOT, RESISTANCE WAS MET WHEN IT WAS HALF WAY CLOSED. A LITTLE FORCE WAS USED AND THE LEVER CLOSED, CLOSING THE FOOT. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT ANY ADVERSE PATIENT EFFECTS. THE SUTURES ACHIEVED HEMOSTASIS. THE PHYSICIAN THOUGHT THERE WAS A MECHANICAL PROBLEM WITH THE DEVICE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATH: 6FOTHER: ASPIRIN