BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1832312 · Received September 3, 2010

    Report

    Report Number
    2953144-2010-01825
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE ISSUE: CAP OF THE SHEATH SEPARATED. TIME OF DEVICE ISSUE: DURING UNPACKING. ADVERSE EVENT: NONE. IT WAS REPORTED THAT DURING UNPACKING OF THE STARCLOSE SE DEVICE, IT WAS FOUND THAT THE CAP OF THE SHEATH WAS SEPARATED IN THE STERILE PACKAGE. A SECOND STAR CLOSE SE DEVICE WAS USED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. 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 REDWOOD CITY NA 90004-6H

    Patients

    Seq Age Sex Outcome Treatment
    1