BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HST III SYSTEM (4.3MM)

    MDR report key: 20879319 · Received December 9, 2024

    Report

    Report Number
    2242352-2024-0001337
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    November 15, 2024
    Report Date
    February 12, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    UDI-DI
    00607567700321
    PMA / PMN Number
    K130382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TW # (B)(4). CORRECTED SECTION: H6 DEVICE CODE CHANGED TO 4042. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 12/03/2024. AN INVESTIGATION WAS CONDUCTED ON 01/13/2025. 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 LOADING DEVICE WITH THE SEAL DEPLOYED. THE BLUE SLIDE LOCK WAS OFF, WHICH ALLOWS FOR THE WHITE PLUNGER TO BE DEPRESSED. THE WHITE PLUNGER WAS 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 CRACKS OR DELAMINATION WAS OBSERVED. 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 NOT CONFIRMED. THE LOT # 3000371361 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 ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM.

    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.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A CORONARY BYPASS PROCEDURE, HEARTSTRING III SYSTEM 4.3MM SEAL DID NOT FIT INSIDE THE AORTA AND CAME OUT OF THE BODY, MAKING IT UNUSABLE. A NEW HEARTSTRING WAS OPENED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO HEALTH RISKS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106405 HST III SYSTEM (4.3MM) CLAMP, VASCULAR DXC MAQUET CARDIOVASCULAR LLC HSK-3043 3000371361 00607567700321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown