BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III SYSTEM 3.8MM

    MDR report key: 20383388 · Received October 7, 2024

    Report

    Report Number
    2242352-2024-0001104
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 16, 2024
    Report Date
    November 18, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700314
    PMA / PMN Number
    K130382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). CORRECTED SECTIONS: D4 UNIQUE IDENTIFIER (UDI) # CORRECTED FROM "(B)(4)" TO "(B)(4)". THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 10/04/2024. AN INVESTIGATION WAS CONDUCTED ON 11/05/2024. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. THE DELIVERY DEVICE WAS RETURNED OUTSIDE THE LOADING DEVICE WITH THE WHITE PLUNGER DEPRESSED AND THE BLUE SAFETY LOCK OFF, WHICH ALLOWS FOR THE WHITE PLUNGER TO BE DEPRESSED. THE SEAL AND TENSION SPRING ASSEMBLY WAS OBSERVED OUTSIDE THE DELIVERY DEVICE IN AN UNRAVELED STATE. THE BLUE TENSION SPRING WAS OBSERVED TO BE CUT INDICATING AN ATTEMPT WAS MADE TO REMOVE THE SEAL AND TENSION SPRING ASSEMBLY FROM THE AORTA. NO MEASUREMENTS OF THE DELIVERY TUBE WERE TAKEN DUE TO THE PRESENCE OF BLOOD IN THE DELIVERY TUBE, PER REQUIREMENT IN (B)(4) SECTION 7.4.1. THIS REQUIREMENT IS CURRENTLY BEING ASSESSED UNDER CAPA 1112811 IN RESPONSE TO FDA OBSERVATION 4A2A. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE PHOTOGRAPHIC EVALUATION AS WELL THE EVALUATION RESULTS, THE REPORTED FAILURE "ACTIVATION PROBLEM" WAS NOT CONFIRMED. SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM. THE LOT # 3000341318 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.

    Additional Manufacturer Narrative · 0

    TW ID (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HST III SYSTEM (3.8MM) AFTER USING THE AORTIC CUTTER, A SEAL WAS INSERTED, BUT BLEEDING FROM THE INSERTION SITE DID NOT STOP, SO IT WAS DETERMINED THAT THE SEAL HAD NOT BEEN PROPERLY DEPLOYED AND A NEW HEARTSTRING WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2547232 HEARTSTRING III SYSTEM 3.8MM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC HSK-3038 3000341318 00607567700314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown