BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2874379 · Received December 14, 2012

    Report

    Report Number
    2024168-2012-07967
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 27, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 EVENT WAS CONFIRMED AS THE DEVICE WAS OBSERVED TO BE PARTIALLY DEPLOYED DURING ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD (LHR) FOR THE REPORTED LOT REVEALED THERE WERE NO ASSOCIATED NONCONFORMING MATERIAL RECORDS (NCMRS), INDICATING ALL LOT RELEASE TESTING MET SPECIFICATIONS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED PER LOCAL QUALITY SYSTEM PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC CORONARY ANGIOGRAM, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE. REPORTEDLY, DURING THUMB ADVANCER/EXCHANGE SHEATH SPLITTING RESISTANCE WAS MET AND THE STARCLOSE SE CLIP WAS NOTED TO BE EXPOSED ON THE CLIP DELIVERY TUBESET. 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 PHYSICIAN 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
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 20810K1

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention SHEATH: 6-FRENCH