BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1842215 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01941
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    January 14, 2010
    Report Date
    January 15, 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
    TX, US
    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 ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHILE ADVANCING THE THUMB ADVANCER, THE SHEATH STARTED TO CARVE. THUMB ADVANCEMENT WAS CONTINUED AND THE CLIP WAS DEPLOYED, BUT THE DEVICE WAS DIFFICULT TO REMOVE. IN ACCORDANCE WITH THE INSTRUCTION FOR USE AN ATTEMPT TO REMOVE THE STARCLOSE SE DEVICE BY RELEASING THE LOCKING MECHANISM ON THE THUMB ADVANCER USING THE ACCESS PORTS WAS MADE; HOWEVER, IT WAS UNSUCCESSFUL. THE DEVICE WAS ULTIMATELY REMOVED USING COUNTER-TRACTION AND AN ASSERTIVE PULL. HEMOSTASIS WAS ACHIEVED WITH THE CLIP, BUT MANUAL COMPRESSION WAS APPLIED FOR 3 MINUTES FOR OOZING. AFTER REMOVAL OF THE DEVICE, IT WAS NOTICED THAT THE SHEATH WAS CARVED AND FRAYED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 83001-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention