BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III SYSTEM 4.3MM

    MDR report key: 20369562 · Received October 4, 2024

    Report

    Report Number
    2242352-2024-0001101
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 13, 2024
    Report Date
    November 15, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    UDI-DI
    00607567700321
    PMA / PMN Number
    K130382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED SECTIONS: B4, G3, G6, H2, H3, H6, H11. CORRECTED SECTION: D4 UDI#. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 09/27/2024. AN INVESTIGATION WAS CONDUCTED ON 10/16/2024. 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 FULLY DEPRESSED AND THE BLUE SAFETY LOCK OFF, WHICH ALLOWS FOR THE WHITE PLUNGER TO BE DEPRESSED. BLOOD WAS OBSERVED ON THE DELIVERY DEVICE AS WELL AS ON THE SEAL INSIDE THE DELIVERY DEVICE. THE SEAL WAS OBSERVED IN A ROLLED STATE INSIDE THE DELIVERY DEVICE. THE SEAL AND TENSION SPRING ASSEMBLY WAS REMOVED FROM THE DELIVERY DEVICE WITH NO PHYSICAL OR VISUAL DIFFICULTIES OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT SEAL OR TENSION SPRING ASSEMBLY. NO MEASUREMENTS OF THE DEVICE WERE TAKEN DUE TO THE PRESENCE OF BLOOD IN THE DELIVERY TUBE, PER REQUIREMENT IN GA000080 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 EVALUATION RESULTS, THE REPORTED FAILURE "ACTIVATION PROBLEM" WAS CONFIRMED. THE LOT # 3000379223 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE TWO 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. SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM.

    Additional Manufacturer Narrative · 0

    TW ID# (B)(4) THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 0

    N/A.

    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 FROM THE DELIVERY TUBE INTO THE AORTOTOMY AFTER PUSHING THE PLUNGER. THERE WAS MINIMAL BLOOD LOSS THAT DID NOT REQUIRE A TRANSFUSION. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY TO OPEN THE NEW DEVICE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553574 HEARTSTRING III SYSTEM 4.3MM CLAMP, VASCULAR DXC MAQUET CARDIOVASCULAR LLC HSK-3043 3000379223 00607567700321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown