BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULARY CLOSURE SYSTEM

    MDR report key: 9447040 · Received December 10, 2019

    Report

    Report Number
    2024168-2019-14360
    Event Type
    Injury
    Date Received
    December 10, 2019
    Date of Event
    November 15, 2019
    Report Date
    February 10, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648079467
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. IT SHOULD BE NOTED THAT THE ELECTRONIC STARCLOSE INSTRUCTIONS FOR USE (IFU),STATES: THE STARCLOSE SE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE INTERVENTIONAL ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH. DO NOT USE THE STARCLOSE SE VASCULAR CLOSURE SYSTEM IF THE PUNCTURE SITE IS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY OR THE PROFUNDA FEMORIS ARTERY, SINCE SUCH PUNCTURE SITES MAY RESULT IN A PSEUDOANEURYSM, INTIMAL DISSECTION, OR AN ACUTE VESSEL CLOSURE (THROMBOSIS OF SMALL ARTERY LUMEN). PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. THE IFU ALSO STATES: THE STARCLOSE SE VASCULAR CLOSURE SYSTEM SHOULD BE USED ONLY BY OPERATORS TRAINED IN DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES WHO HAVE BEEN CERTIFIED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR INC. IT IS UNKNOWN IF THESE IFU DEVIATIONS CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2019001. (B)(4). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THE DEVICE WAS REPORTEDLY DISCARDED. 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 RIGHT SUPERFICIAL FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE WITH AN 9F SHEATH AFTER AN EMERGENT INTERVENTIONAL BRAIN PROCEDURE TO TREAT STROKE. REPORTEDLY, THE STARCLOSE SE CLIP WAS DEPLOYED IN THE POSTERIOR WALL OF THE ARTERY. THE PATIENT HAD A COLD LEG. SURGERY WAS PERFORMED TO REMOVE THE STARCLOSE SE CLIP AND AN ENDARTERECTOMY OF THE SUPERFICIAL FEMORAL ARTERY AND COMMON FEMORAL ARTERY WAS PERFORMED TO REMOVE THE THROMBOSIS. THE LEG WAS NO LONGER COLD. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE SURGERY. THE PHYSICIAN IS IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE. THE ABBOTT VASCULAR REPRESENTATIVE WAS NOT PRESENT DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242120 STARCLOSE VASCULARY CLOSURE SYSTEM VESSEL CLOSURE CLIP MGB ABBOTT VASCULAR 14679-01 08717648079467

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention SHEATH: 9F HEPARIN