BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HST III SYSTEM (4.3MM)

    MDR report key: 12820063 · Received November 16, 2021

    Report

    Report Number
    2242352-2021-00961
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 18, 2021
    Report Date
    February 1, 2022
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    UDI-DI
    00607567700321
    PMA / PMN Number
    K130382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). TREND ANALYSIS: (4110/213/67) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD NOV2019 THROUGH OCT 2021 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD. COMMUNICATION/INTERVIEWS: (4111/213/67) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION.

    Additional Manufacturer Narrative · 0

    TRACKWISE ID # (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HST III SYSTEM (4.3MM) SEAL DID NOT DEPLOY CORRECTLY. A NEW HSK-3043 WAS OPENED TO COMPLETE THE CASE. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1721656 HST III SYSTEM (4.3MM) CLAMP, VASCULAR DXC MAQUET CARDIOVASCULAR LLC HST III SYSTEM (4.3MM) 00607567700321

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown