BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3150715 · Received June 6, 2013

    Report

    Report Number
    2024168-2013-03540
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND CONFIRMED A FAILURE MODE THAT WOULD PREVENT THE CLIP FROM BEING DEPLOYED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE MANUFACTURING OF THE REPORTED LOT REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS (NCMRS). A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO OTHER SIMILAR INCIDENTS. BASED ON THE RELATED RECORDS REVIEW, REVIEW OF THE ELHR FOR THIS LOT AND EXPANDED RECORDS REVIEW, THERE IS NO INDICATION THAT THE LARGER POPULATION OF PRODUCT IS AFFECTED, AS THIS APPEARS TO BE AN ISOLATED INCIDENT. THE PERFORMANCE OF THESE DEVICES WILL CONTINUE TO BE MONITORED.

    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. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE WITH A 6FR SHEATH, AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE THUMB ADVANCER WAS PUSHED, THE CLIP DID NOT DEPLOY. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE TECHNICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249867 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 30206K1

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention SHEATH: 6F