BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1911109 · Received November 30, 2010

    Report

    Report Number
    2953144-2010-03032
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED. THE LOCATOR WINGS WERE SEVERELY BENT AND THE SAFETY RELEASE BUTTON HAD BEEN PUSHED INWARD OUT OF ITS RETAINING TABS. DURING CLIP DEPLOYMENT THE LOCATOR WINGS ARE DESIGNED TO AUTOMATICALLY COLLAPSE SO AS NOT TO INTERFERE WITH THE CLIP DEPLOYMENT; HOWEVER, THE LOCATOR WINGS OF THIS DEVICE WERE BENT. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE ROOT CAUSE FOR THE BENT LOCATOR WINGS IS DUE TO TISSUE COMPRESSED BETWEEN THE TUBES AND OPEN LOCATORS. THIS CREATED DISTAL FORCE DURING THUMB ADVANCEMENT, BENDING THE LOCATOR WINGS AND CREATING THE DIFFICULT REMOVAL CONDITION. THE ROOT CAUSE FOR THE DIFFICULT DEVICE REMOVAL WAS RELATED TO OPERATIONAL CONTEXT AND NOT AN INDICATOR OF A LOT SPECIFIC ISSUE. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEVICE RETURNED FOR NON-SPECIFIED REPAIR. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO COMPLAINT ON EVALUATION DUE TO THE ATTACHMENT FOOT BEING DAMAGED BY TOOL CONTACT. ON FOLLOW-UP, IT WAS NOTED THAT THIS WAS IDENTIFIED DURING A PROCEDURE AND IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER THE CLIP WAS FIRED, THE DEVICE COULD NOT BE REMOVED. THE LOCATOR WINGS WERE COLLAPSED AND THE DEVICE WAS REMOVED. HEMOSTASIS WAS ACHIEVED WITH THE CLIP OF THE STARCLOSE DEVICE. 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 900296H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention