BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT RA DUAL LUMEN CATHETER, 19FR

    MDR report key: 16083092 · Received January 2, 2023

    Report

    Report Number
    3011468686-2022-00021
    Event Type
    Injury
    Date Received
    January 2, 2023
    Date of Event
    November 29, 2022
    Report Date
    January 2, 2023
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    PMA / PMN Number
    K203409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EXAMINATION FOUND NO PROBLEM. THE REPORTING PHYSICIAN NOTED THAT CHECKING THE CATHETER POSITION WITH THE OSCILLATOR ON REST SETTINGS BEFORE SECURING THE CATHETER WILL NOW BE A PART OF THE POST CANNULATION CHECK LIST; NOTING THE DIAPHRAGM POSITION MOVED BECAUSE THE PATIENT WAS INITIALLY ON MAXIMUM OSCILLATOR SETTING.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A 1 YEAR 2 MONTH OLD MALE PATIENT (14.2KG), WITH A HISTORY OF ACUTE RESPIRATORY FAILURE AND PFO, WAS CANNULATED WITH A 19FR CRESCENT RA DUAL LUMEN CATHETER USING OPEN SELDINGER METHOD. IT WAS REPORTED THAT THE DIAPHRAGM POSITION MOVED WHEN THE VENTILATION WAS CHANGED FROM MAXIMUM OSCILLATOR SETTING TO THE REST SETTING AND THE CATHETER MOVED, RESULTING IN THE CATHETER BEING PLACED TOO LOW. THE CATHETER WAS SECURED IN MULTIPLE LOCATIONS INCLUDING THE SUTURE COLLAR; ECHO AND CHEST X-RAY WERE USED DURING PLACEMENT. AT APPROXIMATELY 2200 HOURS, AFTER BEING PLACED ON ECMO, THE PATIENT EXPERIENCED HYPOTENSION AND WAS TREATED WITH VOLUME BOLUSES. THE PATIENT THEN EXPERIENCED BRADYCARDIA AND HYPOTENSION; CHEST COMPRESSIONS WERE STARTED FOR APPROXIMATELY 30 SECONDS TO 1 MINUTE. AFTER CARDIAC COMPRESSIONS, A STAT ECHO REVEALED A PERICARDIAL EFFUSION ALONG THE RIGHT HEART BORDER WITH A CLOT. HEMODYNAMICS AND CIRCUIT WERE STABLE AND THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM. THE CLOT WAS REMOVED AND THE EFFUSION DRAINED. THE TIP OF THE CATHETER PERFORATING THE INFERIOR RA JUNCTION, APPROXIMATELY 1-2CM ABOVE THE IVC, WITH NO ACTIVE BLEEDING WAS VISUALIZED; ALSO REPORTED TO BE OBSERVED ON X-RAY. THE PERFORATION WAS CLOSED AND THE CATHETER POSITION WAS ADJUSTED UNDER TEE GUIDANCE. NO DISRUPTIVE VV ECMO FLOW. HEMODYNAMICS AND SATS WERE STABLE, STERNUM CLOSED AND ANTERIOR CHEST TUBE PLACED. PATIENT WAS TRANSFERRED TO ICU ON (B)(6) 2022, THE PATIENT WAS DECANNULATED. THE PATIENT'S CURRENT STATUS WAS REPORTED AS EXTUBATED AND STABLE. IT WAS REPORTED THAT THE PLACEMENT OF THE CATHETER WAS LIKELY LOWER THAN IDEAL, THE CATHETER MAY HAVE MOVED WITH CHANGE IN VENTILATION SUPPORT, PATIENT AGITATION, AND THE PATIENT ALSO RECEIVED CARDIAC COMPRESSIONS FOR A SHORT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2303808 CRESCENT RA DUAL LUMEN CATHETER, 19FR DUAL LUMEN ECMO CANNULA PZS MC3 INC. 70419 2108118

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Male Required Intervention