BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851644 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02275
    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
    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 EVENT WAS NOTED DURING THE LITERATURE REVIEW. A RETROSPECTIVE STUDY WAS CONDUCTED ON 221 PATIENTS TREATED WITH A STARCLOSE DEVICE IN A 12 MONTH PERIOD BETWEEN (B)(6) 2005 AND (B)(6) 2006. IN THIS PATIENT, IT WAS REPORTED THERE WAS A SIGNIFICANT PERISHETH BLEEDING THROUGHOUT THE PROCEDURE. THE PATIENT HAD AN ASYMPTOMATIC POST PROCEDURAL DROP IN HEMOGLOBIN AND A RETROPERITONEAL HEMATOMA WAS SUSPECTED BUT UNCONFIRMED. THE STARCLOSE WAS SUCCESSFULLY DEPLOYED AND NO FURTHER TREATMENT WAS NEEDED.

    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 79 YR Required Intervention SHEATH: 5F| OTHER: HEPARIN