BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851642 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02274
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    November 1, 2005
    Report Date
    September 27, 2007
    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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. R WILLIAMS, ET AL; "MULTICENTER SAFETY EFFICACY ANALYSIS OF ASSISTED CLOSURE AFTER ANTEGRADE ARTERIAL PUNCTURES USING THE STARCLOSE DEVICE", (JOURNAL OF ENDOVASCULAR THERAPIES 2007; 14:498-505).

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE REVIEW. A RETROSPECTIVE STUDY WAS CONDUCTED ON 221 PATIENTS TREATED WITH A STARCLOSE DEVICE IN A 12 MONTH PERIOD BETWEEN (B)(6) 2005 TO (B)(6) 2006 AT 5 CENTERS. FIVE CASES WERE ATTRIBUTED TO THE DEVICE. IN 3 PATIENTS, THE STARCLOSE CLIP APPLIER WAS DIFFICULT TO INSERT INTO THE EXCHANGE SHEATH. ALTHOUGH, THE DEVICE APPEARED TO DEPLOY APPROPRIATELY, HEMOSTASIS WAS NOT ACHIEVED. HEMOSTASIS WAS SUCCESSFUL WITH "PRESSURE." NO ADDITIONAL INFORMATION 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 Required Intervention OTHER: HEPARIN