BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROVENT-PTO

    MDR report key: 16433953 · Received February 24, 2023

    Report

    Report Number
    3006942548-2023-00003
    Event Type
    Injury
    Date Received
    February 24, 2023
    Report Date
    November 15, 2023
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER STATEMENT: MANUFACTURING DOCUMENTS OF THE CORRESPONDING SN (B)(4) WERE ALREADY CHECKED AND FOUND TO BE CORRECT. AFTER ARRIVAL OF THE CATHETER AT THE PLANT AN INITIAL CHECKUP IN AIR AT ROOM TEMPERATURE WAS PERFORMED. THE CATHETER HAS SHOWN A PTIO2 VALUE OF 176,6 MMHG ON AIR AND A VALUE OF 164,6 MMHG IN 37°C WATER BATH, WHICH IS WITHIN SPECIFICATION. THE CONNECTOR WAS OPENED AND VISUALLY INSPECTED TO CHECK IF THE PCB WAS EXPOSED TO MOISTURE OR A HIGH PULLING FORCE. ALL FOUR WIRES WERE STILL CONNECTED TO THEIR RESPECTIVE SOLDERING PADS AND NO SIGNS OF MOISTURE COULD BE FOUND. ADDITIONALLY, THE PINS ON THE PLUG WERE CHECKED AND NO ABNORMALITIES WERE FOUND. IT WAS FURTHER INVESTIGATED, IF THE MICROCHIP SHOWS ANY SIGNS OF MECHANICAL DAMAGE, THE MEASUREMENT WINDOW WAS VISUALLY INSPECTED. NO DAMAGE ON THE SILICONE OR THE CHIP WAS FOUND. TO VERIFY THE CORRECT FUNCTIONALITY OF THE OXYGEN PARTIAL PRESSURE MEASUREMENT THE CATHETER UNDERWENT A TEST PROCEDURE, CONSISTING OF AN OXYGEN FREE SOLUTION AND AN AERATED VESSEL, IN WHICH THE CATHETER WAS PUT SUCCESSIVELY. IN BOTH CASES THE CATHETER MEASURED VALUES ON THE HIGHER SIDE OF THE SPECIFICATION. THE DESCRIBED ERROR OF SHOWING IMPLAUSIBLE LOW PTIO2 VALUES COULD NOT BE RECREATED UNDER LABORATORY CONDITIONS. IN CONTRARY THE CATHETER MEASURED TOO HIGH PTIO2 VALUES AT LOW LEVELS OF OXYGEN. HOWEVER, AS ALREADY DESCRIBED ABOVE, THE CATHETER REGISTERS CHANGES IN THE PARTIAL PRESSURE OF THE OXYGEN AND MEASURES THEM ACCORDINGLY. THIS INDICATES A LEAKAGE. THEREFORE THE CATHETER TIP WAS SUBMERGED AND PRESSURE FROM THE CONNECTOR SIDE WAS APPLIED TO SEE IF A BUBBLE WILL BE SEEN. THIS WAS THE CASE. TO FULLY UNDERSTAND THE ROOT-CAUSE OF THIS LEAKAGE FURTHER INVESTIGATIONS ARE NECESSARY.

    Additional Manufacturer Narrative · 0

    MANUFACTURER STATEMENT: MANUFACTURING DOCUMENTS OF THE CORRESPONDING SN:(B)(6) WERE ALREADY CHECKED AND FOUND TO BE CORRECT. AFTER ARRIVAL OF THE CATHETER AT THE PLANT AN INITIAL CHECKUP IN AIR AT ROOM TEMPERATURE WAS PERFORMED. THE CATHETER HAS SHOWN A PTIO2 VALUE OF 176,6 MMHG ON AIR AND A VALUE OF 164,6 MMHG IN 37°C WATER BATH, WHICH IS WITHIN SPECIFICATION. THE CONNECTOR WAS OPENED AND VISUALLY INSPECTED TO CHECK IF THE PCB WAS EXPOSED TO MOISTURE OR A HIGH PULLING FORCE. ALL FOUR WIRES WERE STILL CONNECTED TO THEIR RESPECTIVE SOLDERING PADS AND NO SIGNS OF MOISTURE COULD BE FOUND. ADDITIONALLY, THE PINS ON THE PLUG WERE CHECKED (FIG. 06) AND NO ABNORMALITIES WERE FOUND. IT WAS FURTHER INVESTIGATED, IF THE MICROCHIP SHOWS ANY SIGNS OF MECHANICAL DAMAGE, THE MEASUREMENT WINDOW WAS VISUALLY INSPECTED. NO DAMAGE ON THE SILICONE OR THE CHIP WAS FOUND. TO VERIFY THE CORRECT FUNCTIONALITY OF THE OXYGEN PARTIAL PRESSURE MEASUREMENT THE CATHETER UNDERWENT A TEST PROCEDURE, CONSISTING OF AN OXYGEN FREE SOLUTION AND AN AERATED VESSEL, IN WHICH THE CATHETER WAS PUT SUCCESSIVELY. IN BOTH CASES THE CATHETER MEASURED VALUES ON THE HIGHER SIDE OF THE SPECIFICATION. THE DESCRIBED ERROR OF SHOWING IMPLAUSIBLE LOW PTIO2 VALUES COULD NOT BE RECREATED UNDER LABORATORY CONDITIONS. IN CONTRARY THE CATHETER MEASURED TOO HIGH PTIO2 VALUES AT LOW LEVELS OF OXYGEN. HOWEVER, AS ALREADY DESCRIBED ABOVE, THE CATHETER REGISTERS CHANGES IN THE PARTIAL PRESSURE OF THE OXYGEN AND MEASURES THEM ACCORDINGLY. THIS INDICATES A LEAKAGE. THEREFORE THE CATHETER TIP WAS SUBMERGED AND PRESSURE FROM THE CONNECTOR SIDE WAS APPLIED TO SEE IF A BUBBLE WILL BE SEEN. THIS WAS THE CASE. TO FULLY UNDERSTAND THE ROOT-CAUSE OF THIS LEAKAGE FURTHER INVESTIGATIONS ARE NECESSARY. UPDATE 2023-11-08: ACCORDING TO THE INVESTIGATION REPORT DATED 2023-10-06 NO SIGNIFICANT CHANGES IN THE MEASURING FUNCTION OF THE PTIO2 WAS FOUND. THE DESCRIBED ERROR BY THE CUSTOMER OF MEASURING TOO LOW OXYGEN VALUES CANNOT BE RECREATED UNDER LABORATORY CONDITION. ON THE CONTRARY, THE RESULTS SHOW THAT THE CATHETER CANNOT BE THE CAUSE FOR THE DESCRIBED ERROR. BLEEDING IN THE PUNCTURE CHANNEL WHICH CAN OCCUR DURING APPLICATION OF THE CATHETER IS KNOWN TO HAVE AN INFLUENCE ON THE PITO2 VALUE, AS WELL AS APPLICATION IN TISSUE WITH REDUCED OXYGEN-RICH BLOOD SUPPLY. THESE POINTS COULD BE AN EXPLANATION FOR THE DESCRIBED ERROR BY THE CUSTOMER OF MEASURING TOO LOW OXYGEN VALUES. THE INVESTIGATIONS CARRIED OUT CONFIRM THE SENSITIVITY OF THE CATHETER. THIS MEANT THAT IT WAS POSSIBLE TO RECORD CHANGES IN THE PTIO2 MEASUREMENT AT ANY TIME. IT CAN THEREFORE BE RULED OUT THAT THE CATHETER COMPLAINED ABOUT IS RESPONSIBLE FOR THE BEHAVIOR OBSERVED BY THE USER (TOO LOW PTIO2 VALUES).

    Description of Event or Problem · 0

    ON JANUARY 26TH 2023 WE RECEIVED VERBAL NOTIFICATION THAT THE NEUROVENT-PTO SN (B)(4) IS REPORTING PTIO2-VALUES AFTER IMPLANTATION THAT WERE PERCEIVED TO BE TOO LOW. QUESTIONS SHOWED THAT THE PATIENT WAS DOING WELL AND NO PROBLEMS OCCURRED. INITIALLY, AN NEUROVENT-PTO WAS SET WHERE THE O2 WAS ALSO TOO LOW. THIS CATHETER IS NO LONGER AVAILABLE. A SECOND NEUROVENT-PTO WAS THEN PLACED IN THE SAME BOREHOLE AND BOLT. THE O2 VALUE WAS 7 MMHG. THIS WAS SENT TO RAUMEDIC FOR ANALYSIS. AS A COMPARATIVE MEASUREMENT, DR. (B)(6) IMPLANTED A LICOX CATHETER AND THIS CATHETER SHOWED A HIGHER VALUE (APPROX. 23 MMHG).

    Description of Event or Problem · 0

    ON JANUARY 26TH 2023, WE RECEIVED VERBAL NOTIFICATION THAT THE NEUROVENT-PTO SN: (B)(6) IS REPORTING PTIO2-VALUES AFTER IMPLANTATION THAT WERE PERCEIVED TO BE TOO LOW. QUESTIONS SHOWED THAT THE PATIENT WAS DOING WELL AND NO PROBLEMS OCCURRED. INITIALLY, AN NEUROVENT-PTO WAS SET WHERE THE O2 WAS ALSO TOO LOW. THIS CATHETER IS NO LONGER AVAILABLE. A SECOND NEUROVENT-PTO WAS THEN PLACED IN THE SAME BOREHOLE AND BOLT. THE O2 VALUE WAS 7 MMHG. THIS WAS SENT TO RAUMEDIC FOR ANALYSIS. AS A COMPARATIVE MEASUREMENT, DR. ARIKAN IMPLANTED A LICOX CATHETER AND THIS CATHETER SHOWED A HIGHER VALUE (APPROX. 23 MMHG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959593 NEUROVENT-PTO NEUROLOGICAL CATHETER GWM RAUMEDIC AG 095008-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention