BEUDAMED
    FDA Adverse Event Death Summary report: N

    HSK III SYSTEM (3.8MM)

    MDR report key: 10788531 · Received November 4, 2020

    Report

    Report Number
    2242352-2020-00964
    Event Type
    Death
    Date Received
    November 4, 2020
    Date of Event
    October 12, 2020
    Report Date
    November 2, 2020
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    UDI-DI
    00607567700314
    PMA / PMN Number
    K130382
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). CORRECTED SECTION: H6- DEVICE CODE CORRECTED TO "FAILURE TO UNFOLD OR UNWRAP" , H6- CORRECTED TO "CRACK". THE LOT # 25149986 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING HST III SYSTEM (3.8MM) . CUSTOMER REPORTS PATIENT DEATH FOLLOWING CABG/ AVR PROCEDURE. CUSTOMER STATES THAT THEY UTILIZED DEVICE AND THAT THE DELIVERY OF THE SEAL FAILED. WHEN DEPLOYED THE SEAL WAS SIDEWAYS AND DID NOT CREATE SEAL. SEAL OPENED PARTIALLY.

    Additional Manufacturer Narrative · 1

    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 · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING HST III SYSTEM (3.8MM) . CUSTOMER REPORTS PATIENT DEATH FOLLOWING CABG/ AVR PROCEDURE. CUSTOMER STATES THAT THEY UTILIZED DEVICE AND THAT THE DELIVERY OF THE SEAL FAILED. WHEN DEPLOYED THE SEAL WAS SIDEWAYS AND DID NOT CREATE SEAL. SEAL OPENED PARTIALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248262 HSK III SYSTEM (3.8MM) CLAMP, VASCULAR DXC MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM) 25149986 00607567700314

    Patients

    Seq Age Sex Outcome Treatment
    1 Death