BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III SYSTEM 3.8MM

    MDR report key: 17190700 · Received June 23, 2023

    Report

    Report Number
    2242352-2023-00504
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    May 31, 2023
    Report Date
    July 17, 2023
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    UDI-DI
    00607567700314
    PMA / PMN Number
    K130382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE 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.

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 06/08/02023. AN INVESTIGATION WAS CONDUCTED ON 06/27/2023. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WERE OBSERVED ON THE SEAL AND DELIVERY TUBE. THE BLUE SLIDE LOCK WAS OBSERVED TO BE OF AND THE WHITE PLUNGER WAS DEPRESSED. THE SEAL AND TENSION SPRING ASSEMBLY WAS OBSERVED TO BE DEPLOYED INSIDE THE DELIVERY DEVICE TUBE. THE SEAL WAS OBSERVED TO FOLDED AND NOT FULLY DEPLOYED, REMAINING PARTIALLY IN THE DELIVERY TUBE. THE SEAL AND TENSION SPRING ASSEMBLY WAS REMOVED FROM THE DELIVERY TUBE WITH NO VISUAL OR PHYSICAL DIFFICULTIES AND WAS OBSERVED TO BE INTACT WITH NO VISUAL DEFECTS. BLOOD WAS OBSERVED INSIDE THE DELIVERY TUBE, INDICATING AN ATTEMPT WAS MADE TO INTRODUCE THE SEAL INTO THE AORTA, HENCE NO MEASUREMENTS WERE TAKEN. BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE INVESTIGATION RESULTS, THE REPORTED FAILURE "ACTIVATION PROBLEM" WAS CONFIRMED. THE LOT #3000312209 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 THE HST III SYSTEM (3.8MM) WAS PROPERLY LOADED INTO DEPLOYMENT DEVICE. HEARTSTRING WOULD NOT DEPLOY WHEN THE DEPLOYMENT BUTTON IS PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823812 HEARTSTRING III SYSTEM 3.8MM CLAMP, VASCULAR DXC MAQUET CARDIOVASCULAR LLC HSK-3038 3000312209 00607567700314

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male UNKNOWN.