BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3100508 · Received May 8, 2013

    Report

    Report Number
    2024168-2013-02881
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED CLIP OF THE DEVICE BEING OBSERVED AT THE DISTAL END OF THE DEVICE BEFORE DEPRESSING THE CLIP DEPLOYMENT BUTTON WAS NOT CONFIRMED. THE RETURNED DEVICE INDICATES THAT THE DEPLOYMENT PROCEDURE WAS NOT PERFORMED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE IFU STATES UNDER THE CLOSURE PROCEDURE SECTION THAT WHILE MAINTAINING DOWNWARD PRESSURE AND DEVICE STABILITY, DEPRESS THE DEPLOYMENT BUTTON WITH THE RIGHT THUMB. AN AUDIBLE CLICK SHOULD BE HEARD. THIS RELEASES THE CLIP TO CLOSE THE ARTERIOTOMY AND COLLAPSES THE LOCATOR WINGS SIMULTANEOUSLY. IN ADDITION, IT WAS ALSO OBSERVED THAT THE DEVICE WAS REMOVED WITHOUT COLLAPSING THE LOCATOR WINGS. THE IFU STATES UNDER THE CLOSURE PROCEDURE SECTION TO SLIDE THE SAFETY RELEASE TO COLLAPSE THE LOCATOR WINGS AND RESET THE PLUNGER. THE LOCATOR WINGS ARE FULLY COLLAPSED WHEN THE NUMBER TWO ON THE PLUNGER EXITS THE NUMBER WINDOW COMPLETELY. 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. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT INDICATED 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 AFTER A CAROTID STENTING PROCEDURE, ARTERIOTOMY CLOSURE WAS ATTEMPTED OF THE COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE. REPORTEDLY, DURING THUMB ADVANCER DEPLOYMENT, THE OPERATOR OBSERVED "FINGERS" DISTALLY ON THE CLIP DELIVERY TUBESET, WHICH WAS BELIEVED TO BE THE STARCLOSE SE CLIP. THE DEVICE WAS REMOVED AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE OPERATOR WAS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200909 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 20614K1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention