BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III SYSTEM 3.8MM

    MDR report key: 20664726 · Received November 12, 2024

    Report

    Report Number
    2242352-2024-0001229
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 17, 2024
    Report Date
    March 20, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    UDI-DI
    00607567700314
    PMA / PMN Number
    K130382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    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. E1: DUE TO CHARACTER LIMITATIONS THE FULL EVENT SITE NAME IS: (B)(6).

    Additional Manufacturer Narrative · 0

    TW # (B)(4). CORRECTED SECTION: H6- PATIENT CODE CHANGED TO 4582. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 11/08/2024. AN INVESTIGATION WAS CONDUCTED ON 11/19/2024. A VISUAL INSPECTION 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 WHITE PLUNGER DEPRESSED AND THE BLUE SAFETY LOCK OFF, WHICH ALLOWS FOR THE WHITE PLUNGER TO BE DEPRESSED. THE SEAL WAS OBSERVED IN AN UNRAVELED STATE, DETACHED FROM THE INTACT TENSION SPRING ASSEMBLY. NO OTHER VISUAL DEFECTS WERE OBSERVED. 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. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURES "UNRAVELED MATERIAL" AND "DETACHMENT OF DEVICE OR DEVICE COMPONENT" WAS CONFIRMED. THE LOT # 3000384620, HISTORY RECORD REVIEW WAS COMPLETED. THERE WAS ONE (01) NCMR, 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 FAILURES.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HST III SYSTEM (3.8MM) TENSION SPRING AND SEAL STEM CAME OUT BUT THE TETHER WAS NOT ATTACHED. NORMALLY, THE SURGEON WOULD CUT THIS. THE HEARTSTRING COIL UNRAVELED WITHOUT HAVING CUT THE BLUE SUTURE FIRST, WHILE THE ANASTOMOSIS IS ONGOING. THEY HELD THEIR FINGER OVER THE HOLE IN AORTA WHILE OBTAINING ANOTHER HEARTSTRING DEVICE. DELAY TO OPEN ANOTHER DEVICE. NO HARM. RELATED COMPLAINT: TRACKWISE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644620 HEARTSTRING III SYSTEM 3.8MM CLAMP, VASCULAR DXC MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM) 3000384620 00607567700314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown