BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC CUTTER 3.8MM

    MDR report key: 6190928 · Received December 20, 2016

    Report

    Report Number
    2242352-2016-01302
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 25, 2016
    Report Date
    November 28, 2016
    Manufacturer
    MAQUET CV
    Product Code
    FZT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THE SAFETY LOCK WAS ENGAGED AND THE ACTUATION BUTTON WAS NOT DEPRESSED. THERE WERE NO SIGNS OF TAMPERING OR DAMAGE TO THE DEVICE. NO VISUAL DEFECTS WERE OBSERVED. TO TEST THE ABILITY OF THE CUTTER TO FIRE, THE LOCK WAS DISENGAGED AND THE PLUNGER WAS PRESSED TO DEPLOY THE NEEDLE. THE NEEDLE DEPLOYED SUCCESSFULLY. THE ACTUATION BUTTON WAS FULLY DEPRESSED INSIDE THE TOOL AND THE CUTTER AND SPIRAL NEEDLE WERE DEPLOYED. THE ACTUATION BUTTON WAS DEPRESSED APPROXIMATELY 1 INCH INSIDE THE TOOL. BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE RESULTS OF THE INVESTIGATION THE REPORTED COMPLAINT FOR THE REPORTED FAILURE MODE "FAILURE TO FIRE" WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. 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 · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, AORTIC CUTTER 3.8 MM ACTUATION BUTTON COULD NOT BE PRESSED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, AORTIC CUTTER 3.8MM ACTUATION BUTTON COULD NOT BE PRESSED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842307 AORTIC CUTTER 3.8MM CUTTER, SURGICAL FZT MAQUET CV 25127564

    Patients

    Seq Age Sex Outcome Treatment
    1