BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1800501 · Received August 12, 2010

    Report

    Report Number
    2953144-2010-01617
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. DEVICE CODE: 2017 - PATIENT SELECTION.

    Description of Event or Problem · 1

    DEVICE ISSUE: DIFFICULT TO DEPLOY-THUMB ADVANCER, DIFFICULT TO REMOVE, FAILURE TO RETRACT-THUMB ADVANCER. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY OF AN OBESE PATIENT AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING THUMB ADVANCER DEPLOYMENT, DIFFICULTY WAS ENCOUNTERED. AFTER CLIP DEPLOYMENT, RESISTANCE WAS FELT DURING DEVICE REMOVAL. AN ATTEMPT WAS MADE TO REMOVE THE DEVICE WITH THE AIDE OF THE ACCESS PORTS AND THE SAFETY RELEASE, BUT BOTH WERE UNSUCCESSFUL. THE DEVICE WAS REMOVED BY "APPLYING PRESSURE ON THE ARTERY AND PULLING." ONCE THE DEVICE WAS REMOVED IT COULD NOT BE CONFIRMED IF THE CLIP HAD DEPLOYED ON THE ARTERY OR REMAINED IN THE DEVICE. MANUAL COMPRESSION WAS APPLIED FOR LESS THAN 10 MINUTES TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 89006-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention