BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3910861 · Received July 2, 2014

    Report

    Report Number
    2024168-2014-04335
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    April 3, 2014
    Report Date
    June 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE RETURNED DEVICE ANALYSIS INDICATES THAT A POSTERIOR CUFF MISS OCCURRED. BASED ON ANALYSIS 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 EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    A PROGLIDE DEVICE WAS RECEIVED IN THE ABBOTT VASCULAR LAB WITH NO REPORTED INFORMATION. THE DEVICE WAS RETURNED WITH BLOOD IN AND ON THE DEVICE. THE SUTURE WAS PARTIALLY EXPOSED FROM THE NEEDLE SLOT. THE PRE-TIED KNOT WAS TIGHT. THE PLUNGER, LINK AND BOTH CUFFS WERE NOT RETURNED. THE LEVER WAS IN THE CLOSED POSITION AND THE FOOT WAS RETRACTED. A DEVICE IN THIS CONDITION WOULD NOT HAVE ACHIEVED HEMOSTASIS. THE SITE WAS CONTACTED AND NO INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388596 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40203K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention