BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 6064985 · Received October 28, 2016

    Report

    Report Number
    2024168-2016-07405
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    October 5, 2016
    Report Date
    December 19, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND ABBOTT VASCULAR (AV) CONFIRMED THE REPORTED ISSUE RELATED TO SHEATH SPLITTING. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NONCONFORMITIES RELATED TO THE REPORTED EVENT. AVS REVIEW OF THE COMPLAINT HANDLING DATABASE IDENTIFIED SIMILAR EVENTS FOR THIS LOT. AV IDENTIFIED A TREND. ROOT CAUSE ANALYSIS CONCLUDED THAT THE TREND IS LIKELY DUE TO A MANUFACTURING ISSUE. IN CASES WHERE THE STARCLOSE SE FAILS TO ACHIEVE HEMOSTASIS, THE RESULTING ACTION IS TO APPLY MANUAL COMPRESSION. THIS MAY RESULT IN A DELAY IN ACHIEVING PATIENT AMBULATION BUT IS NOT SERIOUS OR LIFE THREATENING. WHILE PRODUCT IN THE FIELD WITH THIS ISSUE MAY CAUSE USER DISSATISFACTION, THE RESULT OF THE ISSUE IS A MINOR SAFETY RISK AS HEMOSTASIS MAY BE ACHIEVED USING MANUAL COMPRESSION. AV HAS IMPLEMENTED MITIGATIONS TO ADDRESS THIS ISSUE AND WILL IMPLEMENT CORRECTIVE ACTIONS TO PREVENT RECURRENCE PER INTERNAL SITE OPERATING PROCEDURES. AV WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE WITH A 6FR SHEATH, AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE SHEATH WOULD NOT SPLIT COMPLETELY AND BUNCHED UP ON THE END OF THE DEVICE. THE CLIP WAS NOT DEPLOYED. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN 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
    716499 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 6041841

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6FR