BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCCO MONITORING KIT

    MDR report key: 24385944 · Received February 19, 2026

    Report

    Report Number
    3003263092-2026-000000
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    February 3, 2026
    Report Date
    February 19, 2026
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    UDI-DI
    04250094500757
    PMA / PMN Number
    K991886
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER INSERTION OF CATHETER AND UPON WITHDRAWING THE GUIDEWIRE, IT WAS FOUND THAT THE GUIDEWIRE WAS UNCOILED IN THE MIDDLE. THE GUIDEWIRE HAS BEEN COMPLETELY REMOVED, NO PART WAS LEFT BEHIND. NO SURGICAL INTERVENTION WAS NEEDED TO TAKE OUT IT. THERE WAS NO PATIENT HARM. THE GUIDEWIRE IS AN ACCESSORY AND SUPPLIED WITH THE PRODUCT PICCO MONITORING KIT. THE USE OF ANY TOOLS OR EXCESSIVE FORCE MAY DAMAGE THE CONNECTION COMPONENT AND LEAD TO LEAKINESS. IF RESISTANCE IS ENCOUNTERED WHEN REMOVING THE GUIDEWIRE, THE GUIDEWIRE COULD BE KINKED ABOUT TIP OF CATHETER WITHIN VESSEL. IN THIS CASE WITHDRAW THE CATHETER BY 2 TO 3 CM AND TRY AGAIN TO REMOVE THE GUIDEWIRE. USE OF EXCESSIVE FORCE MAY TEAR OFF THE GUIDEWIRE. THEREFORE, GUIDEWIRE AND CATHETER ARE TO BE REMOVED SIMULTANEOUSLY. DEVICE WAS NOT RETURNED FOR IN-HOUSE INVESTIGATION, HOWEVER PICTURES WERE PROVIDED. THE CAUSE OF THE REPORTED ISSUE HAS BEEN DETERMINED AS RELATED TO UNCOILED GUIDEWIRE. OVERALL, IT IS NOT POSSIBLE TO DEFINE IF THE DEVICE FAILED TO MEET ITS SPECIFICATION WHEN THE PROBLEM OCCURRED. A RELATIONSHIP BETWEEN THE DEVICE AND THE COMPLAINT IS THEREFORE CONSIDERED, IN WORST CASE SCENARIO, AS LIKELY. INFORMATION INDICATES THAT UPON THE COMPLAINT OCCURRENCE THE DEVICE WAS INVOLVED AND USED ON A PATIENT FOR ADVANCED HEMODYNAMIC MONITORING. THIS EVENT OCCURRED ON THE CHINESE MARKET ON A DEVICE THAT IS DISTRIBUTED EXCLUSIVELY OUTSIDE OF THE USA. THEREFORE, NO GUDID INFORMATION EXISTS. UDI INFORMATION PROVIDED IN D4 IS FOR THE OUS DEVICE. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO ¿PICCO MONITORING KIT¿ WHICH IS SOLD IN THE USA UNDER PRIMARY DI NUMBER (B)(4), PREMARKET SUBMISSION NUMBER K991886.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PLACEMENT OF CATHETER OF PICCO MONITORING KIT FAILED. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311615 PCCO MONITORING KIT PROBE, THERMODILUTION KRB PULSION MEDICAL SYSTEMS SE PV8215 24EC07 04250094500757

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown