BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT JUGULAR DUAL LUMEN CATHETER 28 FR

    MDR report key: 11022827 · Received December 16, 2020

    Report

    Report Number
    3011468686-2020-00007
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    November 11, 2020
    Report Date
    December 16, 2020
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    PMA / PMN Number
    K180151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED COMPLAINT DEVICE HAD EVIDENCE OF A KINK, WHICH MAY HAVE LED TO DELAMINATION ON THE INSIDE WALL. OVER TIME AND WITH REPETITIVE BENDING, THE POINT OF FAILURE WAS LIKELY CREATED. RETURNED DEVICE OUTER DIAMETER WAS MEASURED AND MET SPECIFICATION THE SUB-CLAVIAN INSERTION METHOD MAY HAVE CONTRIBUTED TO THE CATHETER KINKING EITHER DURING INSERTION OR MAINTENANCE. REFER TO THE IFU STATEMENTS BELOW. THE SUB-CLAVIAN INSERTION METHOD IS NOT AN INDICATED USE FOR THE CRESCENT CATHETER AND MC3 WARNS THAT INADEQUATE SECUREMENT MAY LEAD TO CATHETER DAMAGE. IFU STATEMENTS: "THE CATHETER IS SECURED BY SUTURE ON THE DESIGNATED AREA AND THE CIRCUIT TUBING SHOULD REMAIN CONTROLLED IN ORDER TO PREVENT MIGRATION, KINKING OR DISLODGEMENT." "INADEQUATE CATHETER SECUREMENT MAY LEAD TO CATHETER DAMAGE OR DISLODGEMENT." "THE CATHETER SHOULD BE INSERTED INTO THE RIGHT INTERNAL JUGULAR VEIN." "WARNING: NEVER KINK THE CATHETER IN THE WIRE REINFORCED SECTION. NEVER USE A CATHETER THAT HAS BEEN KINKED. IF A CATHETER KINK RESULTS IN PERMANENT DEFORMATION OR DAMAGE, THE CATHETER MAY NEED TO BE REPLACED." THE COMPLAINT OF THE MECHANICAL FAILURE IN THE DEVICE WAS CONFIRMED VIA EVALUATION OF THE RETURNED PRODUCT. REVIEW OF THE INFORMATION PROVIDED BY THE SITES AND THE OBSERVATIONS FROM TESTING CONCLUDES THAT THE FAILURE WAS LIKELY CAUSED BY A KINK. THERE WERE NO ANOMALIES IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    DISTRIBUTOR RECEIVED A REPORT THAT A PATIENT WAS CANNULATED FOR ECMO SUPPORT WITH 28 FR DUAL LUMEN CANNULA ON (B)(6) 2020 IN (B)(6). THE ACCESS VESSEL WAS THE SUBCLAVIAN VEIN. PATIENT WAS TRANSFERRED FROM (B)(6) HOSPITAL TO (B)(6) ON (B)(6). AIR BEING ENTRAINED IN THE CANNULA WAS NOTICED BY THE CLINICIAN ON (B)(6). PATIENT HAD SEIZURES AFTER THE EVENT OF (B)(6). CLINICAL TEAM PUT DERMABOND ON CANNULA TO HELP SEAL IT. FOUR DAYS LATER, ON (B)(6), A SECOND AIR ISSUE OCCURRED AND A CANNULA EXCHANGE WAS PERFORMED. THE PATIENT SEIZURES HAVE RESOLVED. PATIENT NOW HAS A IJ AND FEMORAL CANNULA AND IS AWAITING A LUNG TRANSPLANT. PATIENT STATUS DESCRIBED AS OKAY ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487196 CRESCENT JUGULAR DUAL LUMEN CATHETER 28 FR DUAL LUMEN ECMO CATHETER PZS MC3 INC. 70128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other