BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEK DUO VENO-VENOUS CANNULA

    MDR report key: 13936993 · Received March 29, 2022

    Report

    Report Number
    2531527-2022-00020
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    February 27, 2022
    Report Date
    July 28, 2022
    Manufacturer
    CARDIACASSIST INC.
    Product Code
    DWF
    PMA / PMN Number
    K160257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT INVOLVEMENT. CARDIACASSIST INC. MANUFACTURES THE PROTEK 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.

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT REGARDING PROTEKDUO 31 FR FOUND TO BE CRACKED DURING THE DECANNULATION. MEDICAL TEAM WAS NOT ABLE TO REACH FLOW RATES GREATER THEN 4 LMP. PATIENT WAS NOT AFFECTED. THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE CANNULA WAS USED FOR 16DAYS. THE VISUAL INSPECTION CONFIRMED THE PRESENCE OF BUCKLING AT THE TRANSITION REGION AND A BREACH IN THE CANNULA'S OUTER LUMEN. AS PER PROTEKDUO DFU A WARNING RELATED TO Y CONNECTOR AREA IS REPORTED "AVOID KINKING THE PROTEKDUO CANNULA DURING HANDLING AND PREPARATION. NOTE: THE BASKET AREA AROUND THE PROXIMAL HOLES IS MORE SUSCEPTIBLE TO KINKING THAN OTHER AREAS". BASED ON THE ABOVE AND CONSIDERING THAT CANNULA WAS USED FOR 16 DAYS, IT CANNOT BE RULED OUT THAT THE METHOD OF CANNULA SECUREMET CAUSED CONTINUOUS STRESS AT THE TRANSITION REGION LEADING TO HIGH LEVELS OF STRESS WHICH POTENTIALLY LED TO A BREACH IN THE LUMEN. NO OTHER SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY, LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    H.10: LIVANOVA RECEIVED MEDWATCH REPORT FILED BY THE USER REPORTED AN EVENT DESCRIPTION WHICH WAS SLIGHTLY DIFFERENT FROM WHAT STATED IN THE INITIAL REPORT AND FROM WHAT ORIGINALLY REPORTED TO LIVANOVA. IN DETAIL, IN THE MEDWATCH REPORT IT WAS STATED THE FOLLOWING: ¿FLOW ISSUES WITH THE RVAD. THE PATIENT WAS TAKEN TO THE OR AND FOUND A LEAKING AREA OF THE OUTFLOW CANNULA. THE RVAD WAS REMOVED.¿. THROUGH FOLLOW-UP COMMUNICATION LIVANOVA COULD CLARIFY THAT THE PROTEKDUO WAS USED AS AN RVAD AND NOT LVAD AS INITIALLY REPORTED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA RECEIVED REPORT THAT AFTER 16 DAYS OF ECMO SUPPORT OF A 49 YEARS OLD PATIENT, LVAD FLOWS WERE 4 LPM AND MEDICAL STAFF DECIDED TO REMOVE PROTEKDUO FOR BETTER LVAD FLOWS. UPON REMOVAL, THE CANNULA WAS FOUND TO HAVE A FRACTURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588444 PROTEK DUO VENO-VENOUS CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF CARDIACASSIST INC. 5140-5131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown