BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEK DUO VENO-VENOUS CANNULA

    MDR report key: 11790386 · Received May 7, 2021

    Report

    Report Number
    2531527-2021-00017
    Event Type
    Injury
    Date Received
    May 7, 2021
    Report Date
    May 7, 2021
    Manufacturer
    CARDIACASSIST INC.
    Product Code
    DWF
    PMA / PMN Number
    K160257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THROUGH FOLLOW UP COMMUNICATIONS LIVANOVA LEARNED THAT THE PATIENT WAS CANNULATED FOR MULTIPLE WEEKS AND WAS THEN TRANSFERRED TO A DIFFERENT HOSPITAL. IN ADDITION, IT WAS COMMUNICATED THAT NO ISSUE OCCURRED DURING CANNULATION PHASE AND THAT THE PATIENT WAS CANNULATED FOR MULTIPLE WEEKS. BASED ON THE INFORMATION CURRENTLY AVAILABLE, IT CANNOT BE RULED OUT THAT THE MOST LIKELY ROOT CAUSE OF THE REPORTED CANNULA KINK WAS THE MOVEMENT OF THE PATIENT FROM ONE HOSPITAL TO ANOTHER.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    SERIAL/LOT NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. AS THE SERIAL/LOT NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. CARDIAC ASSIST INC. MANUFACTURES THE XPROTEK DUO VENO-VENOUS CANNULA. THE INCIDENT OCCURRED IN (B)(6). LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    LIVANOVA RECEIVED REPORT THAT PROTEKDUO 29 FR CANNULA HAD BEEN KINKED IN THE RIGHT VENTRICLE (RV) AND THE INTERNAL COIL EMBEDDED ITSELF IN THE RV CAUSING EROSION AT THE APEX. WHEN THE PATIENT WAS DECANNULATED, THE CANNULA TORE A HOLE IN THE APEX OF THE RV AND THE PATIENT TAMPONADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690714 PROTEK DUO VENO-VENOUS CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF CARDIACASSIST INC. 5140-4629

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other