BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONARY ARTERY PERFUSION CANNULA

    MDR report key: 14710882 · Received June 16, 2022

    Report

    Report Number
    1718850-2022-00040
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 19, 2022
    Report Date
    August 5, 2022
    Manufacturer
    LIVANOVA USA INC
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT OF THE COMPLAINED CANNULA IS UNKNOWN. THEREFORE, THE EXPIRATION DATE IS UNKNOWN. THE COMPLAINED CORONARY ARTERY PERFUSION CANNULA CATALOGUE ITEM CP-11012 IS NOT DISTRIBUTED IN THE USA AND IT IS FOR EXPORT ONLY. THEREFORE, THE UDI NUMBER IS NOT APPLICABLE. THE COMPLAINED CORONARY ARTERY PERFUSION CANNULA IS SIMILAR TO THE CORONARY ARTERY PERFUSION CANNULA FAMILY ITEM CP-2XXXX. THE COMPLAINED CANNULA HAS BEEN DISPOSED BY THE CUSTOMER THE COMPLAINED CORONARY ARTERY PERFUSION CANNULA CATALOGUE ITEM CP-11012 IS NOT DISTRIBUTED IN THE USA AND IS FOR EXPORT ONLY. THE COMPLAINED CORONARY ARTERY PERFUSION CANNULA IS SIMILAR TO THE CORONARY ARTERY PERFUSION CANNULA FAMILY ITEM CP-2XXXX WHICH ARE DISTRIBUTED IN THE USA (510(K) NUMBER: K130433). THE LOT OF THE COMPLAINED CANNULA IS UNKNOWN. THEREFORE, THE MANUFACTURING DATE IS UNKNOWN. LIVANOVA USA MANUFACTURES COMPLAINED CORONARY ARTERY PERFUSION CANNULA CATALOGUE ITEM CP-11012. THE INCIDENT OCCURRED IN (B)(6). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DISPOSED OFF.

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT STATING THAT CORONARY ARTERY PERFUSION CANNULA PN: CP-11012 WAS FOUND CRACKED. NO INFORMATION OF PIECE OR FRAGMENT FELL INTO THE PATIENT. ACCORDINGLY, NO PATIENT/USER AFFECTED. TO LIVANOVA KNOWLEDGE, NO ADDITIONAL INTERVENTION WAS PERFORMED TO PRECLUDE PATIENT INJURY. NO PHOTOS OR VIDEOS OF THE PRODUCT WERE PROVIDED, AND SINCE THE CUSTOMER THREW THE UNIT NO RETURN FOR FURTHER INVESTIGATION COULD BE PERFORMED. IN ADDITION, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED LOT. DESPITE ATTEMPTS TO COLLECT OTHER INFORMATION, THE CUSTOMER WAS NOT AVAILABLE TO PROVIDE FURTHER DETAILS. IN ADDITION, THE COMPLAINT DATABASE REVIEW HIGHLIGHTED THAT NO SIMILAR EVENT HAS BEEN RECORDED IN THE LAST 4 YEARS. THUS, A SYSTEMATIC FAILURE CAN BE RULED OUT. BASED ON ABOVE, THE ROOT CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY, LIVANOVA WILL KEEP MONITORING THE MARKET. H3 OTHER TEXT : NOT AVAILABLE.

    Description of Event or Problem · 0

    LIVANOVA USA HAS RECEIVED A REPORT ABOUT A SMALL TIP OF THE CANNULA BROKE OFF INTO THE PATIENT. DURING FOLLOW UP WITH THE CUSTOMER IT WAS CLARIFIED THAT: THERE IS NO INJURY TO THE PATIENT AND THE PATIENT IS GOOD. THE SURGEON STATED THAT THE PIECE DID NOT FALL INTO THE PATIENT AND THAT THE CANNULA HAD CRACKED. NO ADDITIONAL INTERVENTION WAS DONE. THE DEVICE IS NOT AVAILABLE SINCE IT WAS DISPOSED BY THE CUSTOMER. NO PICTURE IS AVAILABLE THE ITEM AND THE LOT OF THE CANNULA REMAINS UNKNOWN. WHERE EXACTLY WAS THE CRACK HAS NOT BEEN CLARIFIED.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313913 CORONARY ARTERY PERFUSION CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF LIVANOVA USA INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown