BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMHEART TRANSSEPTAL CANNULA SET-EF

    MDR report key: 1952415 · Received January 3, 2011

    Report

    Report Number
    2531527-2010-00011
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    November 3, 2010
    Report Date
    December 23, 2010
    Manufacturer
    CARDIACASSIST, INC.
    Product Code
    DWF
    PMA / PMN Number
    K052570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DILATOR INVOLVED IN THE EVENT WAS INADVERTENTLY DISCARDED BY THE HOSPITAL AND COULD NOT BE RETURNED FOR ANALYSIS. TESTING OF COMPONENTS FROM THE SAME LOT UNDER FLUOROSCOPY AGAINST A REFERENCE SAMPLE CONFIRMED A REDUCED LEVEL OF RADIOPACITY FOR COMPONENTS IN THAT LOT. THE COMPOUND UTILIZED IN THE DESIGN UTILIZES A MIX OF BISMUTH SUBCARBONATE TO FLUORESCE UNDER FLUOROSCOPY. A CHEMICAL ANALYSIS OF A SAMPLE DILATOR FROM THE SAME LOT WAS PERFORMED, WHICH CONFIRMED A REDUCED LEVEL OF BISMUTH BICARBONATE IN THE MATERIAL. THIS DEFICIENCY RESULTED IN THE REDUCTION OF RADIOPACITY OBSERVED BY THE USER.

    Description of Event or Problem · 1

    CARDIACASSIST WAS NOTIFIED BY THE HOSPITAL THAT WHILE PERFORMING THE TRANSSEPTAL DILATION UNDER FLUOROSCOPIC GUIDANCE, THE CLINICIANS COULD NOT FULLY VISUALIZE THE TRANSSEPTAL DILATOR. THE DILATION WAS COMPLETED USING TACTILE FEEDBACK TO INDICATE WHEN THE INTRACARDIAC SEPTUM HAD BEEN CROSSED. THERE WAS NO ADVERSE IMPACT TO THE PATIENT AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMHEART TRANSSEPTAL CANNULA SET-EF CARDIOPULMONARY BYPASS CANNULA OR TUBING DWF CARDIACASSIST, INC. TANDEMHEART 2010060684

    Patients

    Seq Age Sex Outcome Treatment
    1