BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3941156 · Received July 17, 2014

    Report

    Report Number
    2024168-2014-04583
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 ANGIOPLASTY PROCEDURE. IT WAS REPORTED THAT ONE DAY FOLLOWING THE PROCEDURE AND SUCCESSFUL PLACEMENT OF THE CLIP OF THE STARCLOSE SE DEVICE, THE PATIENT STATED THEY WERE ALLERGIC TO NICKEL. NO SYMPTOMS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419691 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other