BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1844678 · Received September 23, 2010

    Report

    Report Number
    2953144-2010-02041
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN REC'D.

    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 FEMORAL ARTERY AFTER AN INTERVENTRAL PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, AN ATTEMPT WAS MADE TO REMOVE THE DEVICE BY INSERTING A DILATOR INTO THE ACCESS PORTS TO UNLOCK AND RETRACT THE THUMB ADVANCER AND CLIP DELIVERY TUBESET, BUT WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED AFTER ACTIVATING THE SAFETY RELEASE. THE "PUNCTURE SITE WAS NOT DRY"; THEREFORE, CLOSURE WAS NOT SUCCESSFUL. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADD'L INFO 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 88040-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention