BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1842263 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01947
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    August 1, 2009
    Report Date
    October 18, 2009
    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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER COMPLETING ALL DEVELOPMENT STEPS CORRECTLY, THERE WAS SOME OOZING FROM THE SITE WHICH REQUIRED LESS THAN ONE MINUTE OF MANUAL COMPRESSION TO RESOLVE. INFORMATION PROVIDED TO ABBOTT VASCULAR INDICATED THAT THE "NICK AND SPREAD" WAS PERFORMED AT THE END OF THE CASE AS OPPOSED TO THE START AND "THE PATIENT HAD A LOT OF ANTI-COAGULATION ON BOARD, WHICH CAN CONTRIBUTE TO A SKIN OOZE." THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 79028-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention UNSPECIFIED ANTICOAGULANTS