BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 6064165 · Received October 28, 2016

    Report

    Report Number
    2024168-2016-07380
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    October 3, 2016
    Report Date
    February 15, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. (B)(4): PATIENT SELECTION - THE STARCLOSE SE DEVICE WAS USED IN A CALCIFIED ARTERY. PER THE INSTRUCTIONS FOR USE: DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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. THE STARCLOSE SE DEVICE WAS USED IN A CALCIFIED VESSEL. IT SHOULD BE NOTED THE STARCLOSE SE INSTRUCTIONS FOR USE STATES: DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ABBOTT INTERNAL RECALL NUMBER IS 2024168-2/3/2017-001-R. ABBOTT VASCULAR INITIATED A VOLUNTARY FIELD ACTION FOR THE STARCLOSE SE VASCULAR CLOSURE SYSTEM ON JANUARY 30, 2017, [MEDWATCH # 2024168-2017-00941].

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A CALCIFIED COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE WITH A 6F SHEATH AFTER AN ILIAC INTERVENTIONAL PROCEDURE. REPORTEDLY, THE VESSEL LOCATOR WINGS WOULD NOT DEPLOY. MULTIPLE ATTEMPTS WERE MADE. THE PHYSICIAN TRIED TO SPLIT THE SHEATH BUT IT WOULD NOT SPLIT. THE STARCLOSE SE WAS REMOVED AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. 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
    714368 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 6031541

    Patients

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