BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3024214 · Received March 27, 2013

    Report

    Report Number
    2024168-2013-01771
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EXPERIENCE WAS NOT CONFIRMED. ANALYSIS OF THE DEVICE INDICATED THAT THE EXCHANGE SHEATH WAS NOT ATTACHED TO THE CLIP APPLIER CORRECTLY BY THE OPERATOR. THE STARCLOSE SE DEVICE INSTRUCTIONS FOR USE STATE UNDER THE CLOSURE SECTION NOTE: WHEN CONNECTING THE SHEATH HUB TO THE CLIP APPLIER, HOLD THE HUB UP AT THE SAME ANGLE AS THE TISSUE TRACT ABOVE THE SKIN SURFACE. THIS ACTION ALLOWS A FIRM CONNECTION TO BE MADE WITHOUT PUSHING AGAINST THE SKIN. AN AUDIBLE CLICK SHOULD BE HEARD. CHECK TO MAKE SURE THE HUB-TO-CLIP APPLIER ENGAGEMENT IS SECURE BY GENTLY PULLING ON THE SHEATH HUB. 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 PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, ARTERIOTOMY CLOSURE WAS ATTEMPTED OF THE COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE. REPORTEDLY, THE EXCHANGE SHEATH CUTTER DETACHED AND WAS RETRIEVED FROM THE SUBCUTANEOUS TISSUE TRACT. THE DEVICE WAS REMOVED AND A NON-ABBOTT VASCULAR CLOSURE DEVICE WAS USED 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
    126267 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 20810K1

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention SHEATH: 6-FRENCH TERUMO GLIDESHEATHANGIOMAX