BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III SYSTEM 3.8MM

    MDR report key: 20369551 · Received October 4, 2024

    Report

    Report Number
    2242352-2024-0001100
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 16, 2024
    Report Date
    January 30, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    UDI-DI
    00607567700314
    PMA / PMN Number
    K130382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). CORRECTED SECTION: D4 UDI#. THE DEVICE WAS RETURNED TO THE FACTORY ON 09/20/2024. A PHOTOGRAPH WAS PROVIDED BY THE ACCOUNT. A PHOTOGRAPHIC EVALUATION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED ON THE DELIVERY DEVICE. THE SEAL WAS IN OPENED STATE WITH THE TENSION SPRING ASSEMBLY INSIDE THE DELIVERY TUBE. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT SEAL. NO VISUAL DEFECTS WERE OBSERVED. AN INVESTIGATION WAS CONDUCTED ON 10/09/2024. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED ON THE DELIVERY DEVICE AS WELL AS ON THE SEAL. THE DELIVERY DEVICE TUBE WAS OBSERVED TO BE BENT. THE WHITE PLUNGER WAS OBSERVED TO BE DEPRESSED WITH THE BLUE SAFETY LOCK OFF, WHICH ALLOWS FOR THE WHITE PLUNGER TO BE DEPRESSED. THE SEAL WAS OBSERVED IN A OPENED DEPLOYED STATE. 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. THIS REQUIREMENT IS CURRENTLY BEING ASSESSED UNDER CAPA 1112811 IN RESPONSE TO FDA OBSERVATION 4A2A. BASED ON THE PHOTOGRAPHIC EVALUATION WAS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "ACTIVATION PROBLEM" WAS CONFIRMED AS WELL AS THE ANALYZED FAILURE "BENT TUBE" WAS OBSERVED. THE LOT # 3000405699 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. SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE "ACTIVATION PROBLEM" ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HST III SYSTEM (3.8MM) SEAL WAS UNABLE TO BE DEPLOYED. THE DEVICE WAS PREPPED PER IFU INSTRUCTIONS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A MINIMAL DELAY TO OPEN A NEW DEVICE. THERE WAS NO PATIENT HARM. PHOTO PROVIDED BY COMPLAINANT SHOWS THE DELIVERY DEVICE WITH EVIDENCE OF BLOOD WITH THE SEAL STILL ATTACHED TO THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325975 HEARTSTRING III SYSTEM 3.8MM CLAMP, VASCULAR DXC MAQUET CARDIOVASCULAR LLC HSK-3038 3000405699 00607567700314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown