BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1870643 · Received October 12, 2010

    Report

    Report Number
    2953144-2010-02451
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    May 25, 2010
    Report Date
    September 17, 2010
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED, THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A 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 ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE EXCHANGE SHEATH WAS EITHER DIFFICULT TO SPLIT OR FAILED TO SPLIT COMPLETELY. RESISTANCE WAS FELT DURING THUMB ADVANCER DEPLOYMENT. THE PHYSICIAN REPORTED THAT THIS HAS OCCURRED FROM (B)(6) 2010 TO (B)(6) 2010 WITH THE NEW SHEATH MATERIAL. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE OR PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 88025-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention