BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSK III SYSTEM (3.8MM)

    MDR report key: 12314267 · Received August 12, 2021

    Report

    Report Number
    2242352-2021-00663
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Date of Event
    July 26, 2021
    Report Date
    August 13, 2021
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    UDI-DI
    00607567700314
    PMA / PMN Number
    K130382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10 CORRECTION: TREND ANALYSIS: (4110/213/67) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD JUL 2019 TO JUN 2021 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HST III SYSTEM (3.8MM) SEAL DIDN'T DEPLOY PROPERLY. THERE WERE NO PATIENT ISSUES AND THEY HAD TO OPEN ANOTHER KIT TO FINISH THE CASE.

    Additional Manufacturer Narrative · 1

    TRACKWISE ID # (B)(4). ANALYSIS OF PRODUCTION: (3331/213/67) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT 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 MANUFACTURING PROCESS AND THE REPORTED FAILURE. HISTORICAL DATA ANALYSIS: (4109/213/67) THE REVIEW OF THE HISTORICAL DATA INDICATES THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME LOT NUMBER AND REPORTED FAILURE MODE. TREND ANALYSIS: (4110/213/67) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD MAY 2019 THROUGH APR 2021 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD. TESTING OF ACTUAL/SUSPECTED DEVICE/TESTING OF RAW/STARTING MATERIALS: (10/4105/13/22) THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 08/02/2021. AN INVESTIGATION WAS CONDUCTED ON 08/10/2021. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED ON THE LOADING DEVICE. THE DELIVERY DEVICE WAS RETURNED INSIDE THE LOADING DEVICE WITH THE WHITE PLUNGER NOT DEPRESSED AND THE BLUE SLIDE LOCK NOT ENGAGED AND NOT IN ITS NORMAL POSITION. THE SEAL WAS OBSERVED INSIDE THE LOADING DEVICE. THE DELIVERY DEVICE WAS REMOVED FROM THE LOADING DEVICE AND THE SEAL AND TENSION SPRING ASSEMBLY REMAINED INSIDE THE LOADING DEVICE. THE SEAL AND TENSION SPRING ASSEMBLY WAS REMOVED FROM THE LOADING DEVICE WITH NO PHYSICAL OR VISUAL DIFFICULTIES. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE SEAL OR TENSION SPRING ASSEMBLY. MEASUREMENTS OF THE DELIVERY DEVICE WERE TAKEN; THE INNER DIAMETER WAS MEASURED AT 0.196 INCHES, THE OUTER DIAMETER WAS MEASURED AT 0.222 INCHES. THE LENGTH OF THE DELIVERY TUBE WAS MEASURED AT 2.49 INCHES. THE MEASUREMENT VALUES RECORDED FOR THE DELIVERY TUBE WERE WITHIN THE TOLERANCE SPECIFICATIONS. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURE "ACTIVATION PROBLEM" WAS NOT CONFIRMED BUT WAS CONFIRMED FOR THE ANALYZED FAILURE "FITTING PROBLEM".

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HST III SYSTEM (3.8MM) SEAL DIDN'T DEPLOY PROPERLY. THERE WERE NO PATIENT ISSUES AND THEY HAD TO OPEN ANOTHER KIT TO FINISH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211372 HSK III SYSTEM (3.8MM) CLAMP, VASCULAR DXC MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM) 25158457 00607567700314

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR