BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III SYSTEM 3.8MM

    MDR report key: 17573115 · Received August 18, 2023

    Report

    Report Number
    2242352-2023-00676
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    July 26, 2023
    Report Date
    August 18, 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 08/04/2023. AN INVESTIGATION WAS CONDUCTED ON 08/10/2023. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WERE OBSERVED ON THE DEVICE. THE DELIVERY DEVICE WAS RETURNED PLACED BACK IN THE LOADING DEVICE AFTER AN ATTEMPT AT LOADING WAS MADE. THE SEAL WAS VISIBLE IN THE LOADING DEVICE WINDOW OFF-CENTER FROM ITS NORMAL POSITION. THE DELIVERY DEVICE WAS REMOVED FROM THE LOADING DEVICE WITH NO PHYSICAL DIFFICULTIES. THE BLUE SLIDE LOCK WAS ON AND THE WHITE PLUNGER WAS NOT DEPRESSED. THE SEAL WAS REMOVED FROM THE LOADING DEVICE WITH NO PHYSICAL DIFFICULTIES. THE SEAL WAS OBSERVED TO BE PARTIALLY UNRAVELED AND WAS DISCONNECTED FROM THE TENSION SPRING ASSEMBLY. MEASUREMENTS OF THE DELIVERY DEVICE WERE TAKEN; THE INNER DIAMETER WAS MEASURED AT 0.194 INCHES, THE OUTER DIAMETER WAS MEASURED AT 0.22 INCHES. THE LENGTH OF THE DELIVERY TUBE WAS MEASURED AT 2.52 INCHES (MCV00004217). THE MEASUREMENT VALUES RECORDED FOR THE DELIVERY TUBE WERE WITHIN THE TOLERANCE SPECIFICATIONS. BASED ON THE RETURNED CONDITION OF THE DEVICE AND INVESTIGATION RESULTS, THE REPORTED FAILURE "FITTING PROBLEM", AS WELL AS THE ANALYZED FAILURE "UNRAVELED MATERIAL", WAS CONFIRMED. THE LOT # 3000324673 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

    RELATED TO 863884. THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HST III SYSTEM (3.8MM) FAILED TO PROPERLY LOAD IN THE LOADING DEVICE AFTER FOLLOWING IFU. THE WHITE PLUNGER WAS NOT PRESSED. ANOTHER DEVICE OPENED AND THE SAME THING HAPPENED (SEPARATE COMPLAINT COMPLETED). 3RD DEVICE OPENED AND LOADED WITHOUT ISSUE. NO DELAYS. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050592 HEARTSTRING III SYSTEM 3.8MM CLAMP, VASCULAR DXC MAQUET CARDIOVASCULAR LLC HSK-3038 3000324673 00607567700314

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male