BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1920340 · Received December 10, 2010

    Report

    Report Number
    2953144-2010-03192
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. (DATE OF THE EVENT): THE FACILITY REPORTER INDICATED THE EVENT OCCURRED THIS MONTH; THEREFORE, DATE OF (B)(6) 2010 IS BEING USED AS BEST ESTIMATE DATE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED DEVICE FOUND THAT IT WAS PARTIALLY DEPLOYED AND THE CONDITION WAS CONSISTENT WITH THE HUB OF THE EXCHANGE SHEATH NOT SUCCESSFULLY ENGAGED WITH THE DEVICE. SUBSEQUENTLY, THE EXCHANGE SHEATH WAS SEPARATED FROM THE DEVICE WHEN DEPLOYING THE PLUNGER TO INITIATE THUMB ADVANCER AND DELIVERY TUBESET DEPLOYMENT. HOWEVER, BECAUSE THE EXCHANGE SHEATH WAS NOT RETURNED, THIS COULD NOT BE CONFIRMED. DURING TESTING A PROXY SHEATH WAS USED WHICH FULLY ENGAGED WITH THE DEVICE. RE-DEPLOYMENT WAS SUCCESSFUL, THE DEVICE PERFORMED AS DESIGNED. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE PERFORMED ACCORDING TO SPECIFICATION AND A ROOT CAUSE RELATED TO THE DEVICE 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 AN UNSPECIFIED VESEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE PROGLIDE DEVICE FAILED. NO DETAILS WERE RECALLED BY THE PHYSICIAN AS OF HOW THE DEVICE FAILED OR HOW HEMOSTASIS WAS ACHIEVED. THE PHYSICIAN DID NOT REMEMBER THAT THE PATIENT HAD EXPERIENCED ANY ADVERSE EFFECT DUE TO THIS INCIDENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE ERROR 5 METER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-REDWOOD CITY 920346H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention