BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1982056 · Received February 8, 2011

    Report

    Report Number
    2024168-2011-00774
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    November 29, 2010
    Report Date
    January 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP-DEPLOYED WITH ALL EXTERNAL AND INTERNAL COMPONENTS INTACT AND IN THE APPROPRIATE POST CLIP-DEPLOYMENT POSITION. THE VESSEL LOCATOR WINGS WERE COMPLETELY COLLAPSED AND THE SHEATH WAS FULLY SLIT. THERE WERE NO ABNORMAL OBSERVATIONS THAT COULD PREVENT THE CLIP FROM BEING FULLY DELIVERED TO THE ARTERIAL SURFACE TO CLOSE THE ACCESS SITE. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUE WAS 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN USING THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE DEVICE WAS DEPLOYED, BUT HEMOSTASIS WAS NOT ACHIEVED. PULSATILE FLOW WAS PRESENT IN THE ARTERY. MANUAL COMPRESSION WAS APPLIED FOR 15 MINUTES 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-TEMECULA-CT 930426H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention