BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC CUTTERS, 5-PACK (4.3MM)

    MDR report key: 14051122 · Received April 8, 2022

    Report

    Report Number
    2242352-2022-00305
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 12, 2022
    Report Date
    May 13, 2022
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    FTZ
    UDI-DI
    00607567700277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE ID (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP.

    Additional Manufacturer Narrative · 0

    TRACKWISE # (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/SERIAL 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 COMPLAINTS WAS REPORTED FOR THE SAME LOT/SERIAL NUMBER AND REPORTED FAILURE MODE. TREND ANALYSIS: (4110/213/67) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD APR 2020 THROUGH MAR 2022 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE THE AORTIC CUTTERS, 5-PACK (4.3MM) UNLOCK BUTTON WAS HARDER THAN USUAL. THEY DIDN'T USE IT JUST IN CASE, BUT THEY OPENED A NEW PRODUCT OF THE SAME SIZE AND COULD USE IT WITHOUT ANY PROBLEM. THERE IS NO DAMAGE TO THE PATIENT'S HEALTH.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277372 AORTIC CUTTERS, 5-PACK (4.3MM) LOCATOR, MAGNETIC FTZ MAQUET CARDIOVASCULAR LLC AORTIC CUTTERS, 5-PACK (4.3MM) 25157119 00607567700277

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown