BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC CUTTER 3.8MM

    MDR report key: 2128857 · Received June 13, 2011

    Report

    Report Number
    2648729-2010-01670
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 17, 2010
    Report Date
    May 18, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    DWS
    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 WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION, THEREFORE NO EVAL COULD BE PERFORMED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE AC-3038 "CUTTER DID NOT GO OFF." A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE PRODUCT IS NOT RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AORTIC CUTTER 3.8MM CLAMPLESS BEATING HEART SYSTEM DWS MAQUET CARDIOVASCULAR AC-3038 9060571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA