BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 8717094 · Received June 20, 2019

    Report

    Report Number
    2024168-2019-04897
    Event Type
    Injury
    Date Received
    June 20, 2019
    Date of Event
    May 29, 2019
    Report Date
    June 20, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    UDI-DI
    08717648079467
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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). 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 STARCLOSE INSTRUCTIONS FOR USE 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. 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.

    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 5F SHEATH AFTER A DIAGNOSTIC HEART CATHETERIZATION. REPORTEDLY, AFTER THE VESSEL LOCATOR WINGS WERE OPENED AND WHILE RETRACTING THE DEVICE TO PLACE THE WINGS AGAINST THE VESSEL WALL, THE STARCLOSE SE DEVICE PULLED OUT OF THE ARTERY. MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512850 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 08717648079467

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SHEATH: 5F