BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1973234 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00537
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE DISTAL END APPEARED NORMAL AND THE EXCHANGE SHEATH WAS FULLY SLIT. THE VESSEL LOCATOR BUTTON AND THUMB ADVANCER WERE IN A CORRECT POST DEPLOYED POSITIONS. DURING CLIP DEPLOYMENT THE VESSEL LOCATOR WINGS ARE DESIGNED TO AUTOMATICALLY COLLAPSE SO AS NOT TO INTERFERE WITH THE CLIP DEPLOYMENT; HOWEVER, THE VESSEL LOCATOR WINGS OF THIS DEVICE WERE FOUND BROKEN AND BENT. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE CAUSE FOR THE BENT AND BROKEN VESSEL LOCATOR WINGS IS COMPACTION OF SUBCUTANEOUS TISSUE BETWEEN THE DISTAL END OF THE TUBESET AND THE LOCATOR WINGS DURING THUMB ADVANCER DEPLOYMENT. THIS MAY CREATE DISTAL FORCES THAT RESULT IN BENDING AND BREAKAGE OF THE LOCATOR WINGS AND INTERFERE WITH CLIP DEPLOYMENT. 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.

    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 A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE CLIP WAS DEPLOYED, BUT FAILED TO ACHIEVE HEMOSTASIS. THE CLIP WAS NOTICED ON THE END OF THE DEVICE. MANUAL COMPRESSION WAS USED 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 940276H

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention