BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III SYSTEM 3.8MM

    MDR report key: 20523514 · Received October 24, 2024

    Report

    Report Number
    2242352-2024-0001168
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    September 30, 2024
    Report Date
    November 19, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    UDI-DI
    00607567700314
    PMA / PMN Number
    K130382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 10/21/2024. PHOTOGRAPHS WERE PROVIDED BY THE ACCOUNT. A PHOTOGRAPHIC EVALUATION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT AORTIC CUTTER. THE DELIVERY DEVICE WAS RETURNED OUTSIDE THE LOADING DEVICE WITH THE TENSION SPRING ASSEMBLY INSIDE THE DELIVERY DEVICE WITH THE SEAL IN A DEPLOYED OPENED STATE. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT SEAL. PRODUCT INFORMATION WAS ALSO OBSERVED IN THE PHOTOGRAPH. 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 TENSION SPRING ASSEMBLY INSIDE THE DELIVERY DEVICE WITH THE SEAL IN A DEPLOYED OPENED STATE. THE WHITE PLUNGER WAS DEPRESSED AND THE BLUE SAFETY LOCK WAS OFF, WHICH ALLOWS FOR THE WHITE PLUNGER TO BE DEPRESSED. 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. NO MEASUREMENTS OF THE DELIVERY TUBE 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 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 # 3000364553 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. E1 EVENT SITE ADDRESS (B)(6).

    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 (3.8MM) HAD THE DELIVERY DEVICE DEPLOYED BY PRESSING THE PLUNGER AFTER THE AORTIC CUTTER HAD BEEN USED. HOWEVER, THE SEAL DID NOT COME OUT DUE TO A DEFECTIVE PRODUCT. THE IFU STEPS WERE FOLLOWED. IT IS NOT CONFIRMED IF THERE WAS ANY BLEEDING. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ABNORMALITIES IN THE PATIENT'S CONDITION. PHOTO PROVIDED BY COMPLAINANT SHOWS THE DELIVERY DEVICE WITH EVIDENCE WITH THE SEAL STILL ATTACHED TO THE DELIVERY TUBE ALONGSIDE THE AORTIC CUTTER AND LOADING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2561449 HEARTSTRING III SYSTEM 3.8MM CLAMP, VASCULAR DXC MAQUET CARDIOVASCULAR LLC HSK-3038 3000364553 00607567700314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.