BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 6311771 · Received February 8, 2017

    Report

    Report Number
    2024168-2017-01030
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    January 13, 2017
    Report Date
    May 30, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 RELEVANT INFORMATION. ABBOTT VASCULAR INITIATED A VOLUNTARY FIELD ACTION FOR THE STARCLOSE SE VASCULAR CLOSURE SYSTEM ON JANUARY 30, 2017, [MEDWATCH # 2024168-2017-00941]. THE ABBOTT INTERNAL RECALL NUMBER IS 2024168-2/3/2017-001-R.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STARCLOSE SE, LOT NUMBER 6111641, USED IN THIS EVENT IS NOT ASSOCIATED WITH THE VOLUNTARY FIELD ACTION INITIATED ON JANUARY 30, 2017.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND ABBOTT VASCULAR (AV) IDENTIFIED EVIDENCE OF DIFFICULTY SPLITTING THE SHEATH. AV REVIEWED THE LOT HISTORY RECORD AND OTHER SOURCES OF MANUFACTURING DATA. ROOT CAUSE ANALYSIS CONCLUDED THE ISSUE IS LIKELY RELATED TO MATERIAL USED IN THE STARCLOSE MANUFACTURING PROCESS. AV IS WORKING ON POSSIBLE MITIGATIONS TO PREVENT RECURRENCE PER INTERNAL OPERATING PROCEDURES. AV WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT COMMON FEMORAL ARTERIOTOMY CLOSURE WAS ATTEMPTED USING A STARCLOSE SE DEVICE, VIA A 5FR SHEATH, AFTER A DIAGNOSTIC ARTERIAL PROCEDURE. REPORTEDLY, THE CLOSING PROCEDURE WAS PERFORMED CORRECTLY, BUT AFTER TRIGGERING STEP 4 (CLIP DEPLOYMENT) AND REMOVING THE SYSTEM, CLOSURE HAD NOT BEEN DONE. IT WAS NOTICED THAT THE CLIP HAD COME OUT WITH THE SYSTEM HAVING BEEN CAUGHT / HOOKED ON THE STARCLOSE SE SHEATH. HEMOSTASIS WAS ACHIEVED WITH MANUAL ARTERIAL COMPRESSION. THERE WERE NO ADVERSE PATIENT SEQUELAE REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92972 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 6111641

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention