BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC CUTTER 3.8MM

    MDR report key: 2449635 · Received February 1, 2012

    Report

    Report Number
    2242352-2012-00132
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 30, 2012
    Report Date
    February 1, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    FZT
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NONCONFORMANCE ISSUE(S) WITH THIS PRODUCTION LOT. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE NEEDLE DID NOT COME OUT THE AORTIC CUTTER AFTER UNLOCKING. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE HOSPITAL INTENDS TO RETURN THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AORTIC CUTTER 3.8MM CLAMPLESS BEATING HEART FZT MAQUET CARDIOVASCULAR, LLC AC-3038 25043146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA