BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III SYSTEM 3.8MM

    MDR report key: 17592467 · Received August 21, 2023

    Report

    Report Number
    2242352-2023-00679
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    July 25, 2023
    Report Date
    September 6, 2023
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    UDI-DI
    00607567700314
    PMA / PMN Number
    K130382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). UPDATED SECTION: B4, D10, G4, G7, H2, H3, H6, H10. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 08/25/2023. AN INVESTIGATION WAS CONDUCTED ON 08/29/2023. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THE DELIVERY DEVICE WAS RETURNED OUTSIDE THE LOADING DEVICE WITH THE WHITE PLUNGER NOT DEPRESSED AND THE BLUE SAFETY ON, WHICH PREVENTS THE WHITE PLUNGER FROM BEING DEPRESSED. THE SEAL WAS OBSERVED IN THE LOADING DEVICE WINDOW. A MECHANICAL EVALUATION WAS CONDUCTED. THE SEAL AND TENSION SPRING ASSEMBLY WAS REMOVED FROM THE LOADING DEVICE WITH NO PHYSICAL OR VISUAL DIFFICULTIES OBSERVED. THERE WERE NO CRACKS OR DELAMINATION OBSERVED ON THE INTACT SEAL. MEASUREMENTS OF THE DELIVERY DEVICE WERE TAKEN; THE INNER DIAMETER WAS MEASURED AT 1.96 INCHES, THE OUTER DIAMETER WAS MEASURED AT 0.219 INCHES (RM2036883). THE LENGTH OF THE DELIVERY TUBE WAS MEASURED AT 2.48 INCHES (MCV00004217). THE MEASUREMENT VALUES RECORDED FOR THE DELIVERY TUBE WERE WITHIN THE TOLERANCE SPECIFICATIONS. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "ACTIVATION PROBLEM" WAS NOT CONFIRMED, HOWEVER THE ANALYZED FAILURE "FITTING PROBLEM" WAS OBSERVED. THE LOT # 3000298147 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.

    Additional Manufacturer Narrative · 0

    TRACKWISE ID (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    RELATED TO 863588 AND 864452. THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, HST III SYSTEM (3.8MM) GOT STUCK IN THE SHOOTER SO IT COULDN'T BE USED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. A NEW DEVICE WAS USED AND THE CARDIAC SURGICAL INTERVENTION WAS TERMINATED. THERE WAS NO PROCEDURAL DELAY. NO HARM TO THE PATIENT, THE PATIENT HAS COMPLETED THE OPERATION AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330054 HEARTSTRING III SYSTEM 3.8MM CLAMP, VASCULAR DXC MAQUET CARDIOVASCULAR LLC HSK-3038 3000298147 00607567700314

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK.| UNKNOWN.