BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 4130217 · Received September 30, 2014

    Report

    Report Number
    2024168-2014-06324
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 15, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED DATE OF OCCURRENCE, EXACT DATE WAS NOT PROVIDED BY HOSPITAL. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ACHIEVED USING A STARCLOSE SE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, ONE DAY POST-PROCEDURE THE PATIENT CALLED THE PHYSICIAN AND STATED THAT THEY WERE ALLERGY TO NICKEL. THE PATIENT HAS EXPERIENCED NO SYMPTOMS OR EFFECTS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE INITIAL PROCEDURE WAS REPORTED. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607436 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention