BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1032139 · Received April 21, 2008

    Report

    Report Number
    2953144-2008-00771
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    February 1, 2008
    Report Date
    April 1, 2008
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INVOLVES A STUDY NOTED IN AN ARTICLE. NO DEVICES WERE AVAILABLE FOR ANALYSIS. THE PART AND LOT NUMBER WERE NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ATTACHMENT: LIK-WUI TAY, EDGAR, CO, MELISSA, ET AL. "CLINICAL EXPERIENCE OF STARCLOSE VASCULAR CLOSURE DEVICE IN PATIENT'S WITH FIRST AND RECURRENT FEMORAL PUNCTURES." J INTERVEN CARDIOL 2008; 21:67-73.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: UNK. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE REVIEW. A STUDY WAS CONDUCTED IN 103 PT'S WITH FIRST (76%) AND RECURRENT (24%) FEMORAL PUNCTURE ACCESS SITES TO ASSESS VASCULAR COMPLICATIONS WITH THE USE OF THE STARCLOSE DEVICE AFTER PERCUTANEOUS CORONARY INTERVENTIONS. REPORTEDLY, THERE WERE 9 PT'S WHO REQUIRED ADDITIONAL MANUAL COMPRESSION APPLIED FOR MORE THAN 3 MINUTES AFTER CLIP DEPLOYMENT TO ACHIEVE HEMOSTASIS. ADDITIONALLY, THERE WERE 10 CASES OF RECURRENT WOUND BLEEDING REQUIRING MANUAL COMPRESSION IN THE WARDS. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention OTHER: HEPARIN| SHEATH: 7FR SHEATH