BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1920416 · Received December 10, 2010

    Report

    Report Number
    2953144-2010-03196
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND IT WAS A FULLY CLIP DEPLOYED DEVICE, WHICH WAS CONFIRMED TO BE DEPLOYED OUTSIDE OF THE PATIENTS ANATOMY. INSPECTIONS OF THE EXTERNAL AND INTERNAL COMPONENTS WERE IN APPROPRIATE POST CLIP DEPLOYED POSITION. THERE WERE NO ABNORMAL OBSERVATIONS. DURING TESTING, THE DEVICE WAS CLEANED AND REASSEMBLED FOR REDEPLOYMENT AND THE RESULTS WERE SUCCESSFUL. THE PLUNGER WAS SECURELY ENGAGED TO DEPLOY THE LOCATOR WINGS AND THE LOCATOR WINGS REMAINED FULLY OPEN THROUGHOUT THE THUMB ADVANCER STROKE. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE WAS FULLY FUNCTIONAL. THE ROOT CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. 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 RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN ATTEMPTING TO DEPRESS THE PLUNGER AND DEPLOY THE LOCATOR WINGS NO "CLICK" WAS HEARD AND WHEN RETRACTING THE DEVICE OUT OF THE TISSUE TRACT AND THE DEVICE LOST VESSEL ACCESS. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-REDWOOD CITY 860306H

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention