BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2944547 · Received February 5, 2013

    Report

    Report Number
    2024168-2013-00666
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT 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 DIAGNOSTIC CORONARY ANGIOGRAM, ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ACHIEVED USING A STARCLOSE SE DEVICE. REPORTEDLY NEAR COMPLETION OF THUMB ADVANCER/EXCHANGE SHEATH SPLITTING, DISTAL DEPLOYMENT COULD NOT BE COMPLETED. AS THE DEVICE WAS LIFTED, IT WAS OBSERVED THAT THE THUMB ADVANCER WAS NOT COMPLETELY IN THE DEPLOYMENT COMPLETION WINDOW. THE DEVICE WAS EASILY REMOVED. THE LOCATOR WINGS WERE RETRACTED WHEN THE DEVICE WAS REMOVED. IT WAS BELIEVED THAT THE CLIP DEPLOYED PREMATURELY. AFTER MASSAGING THE TISSUE TRACT TO EXPRESS ALL BLOOD, NO FURTHER BLEEDING OCCURRED, INDICATING HEMOSTASIS WAS ACHIEVED. AN HOUR AFTER THE PROCEDURE, THE OPERATOR REASSESSED THE ACCESS SITE FOR ANY HEMATOMAS OR BLEEDING, BUT COMPLETE HEMOSTASIS REMAINED AND THE ACCESS SITE WAS "AS SMOOTH AS IT CAN BE" WITH NO INDICATION OF A HEMATOMA. THE TISSUE TRACT WAS DESCRIBED AS NOT BEING TIGHT BUT LARGE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT 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
    49523 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 20815K1

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR SHEATH: 6-FRENCH