BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1241185 · Received November 20, 2008

    Report

    Report Number
    2953144-2008-01895
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: EVAL OF THE RETURNED DEVICE REVEALED THAT THE DEVICE WAS PARTIALLY DEPLOYED. THE VESSEL LOCATOR WINGS WERE COLLAPSED INTO THE TUBE SET AND THE SAFETY RELEASE BUTTON WAS FULLY PROXIMAL. INTERNAL EXAMINATION REVEALED THAT THE CATCH, TRIGGER PIN, AND PUSHER BLOCK WERE IN THE PRE-DEPLOYMENT POSITIONS. THE CLIP HAD NOT BEEN DEPLOYED. THE DEVICE WAS REASSEMBLED AND THE CLIP WAS DEPLOYED IN THE LAB WITHOUT DIFFICULTY. THE CONDITION OF THE DEVICE DOES NOT MATCH THE REPORTED EXPERIENCE THAT THE CLIP DEPLOYED INTO THE SUBCUTANEOUS TISSUE. IT APPEARS THAT THE VESSEL LOCATORS MAY HAVE BEEN INADVERTENTLY COLLAPSED DURING DEPLOYMENT CAUSING LOSS OF ACCESS; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THERE WERE NO DEFECTS OR ABNORMALITIES DETECTED. THEREFORE, THE ROOT CAUSE FOR THE PARTIAL DEPLOYMENT OF THE DEVICE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS. NO MALFUNCTION OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE HISTORY RECORD FOR THIS DEVICE DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PREMATURE CLIP DEPLOYMENT/MISLOCATION. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. DURING ADVANCEMENT OF THE THUMB ADVANCER, THE CLIP PREMATURELY DEVELOPED INTO THE SUBCUTANEOUS TISSUE. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PT EFFECTS. THOUGH REQUESTED, 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 INC. NA 68029-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention