BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROVENT-P

    MDR report key: 23615654 · Received November 21, 2025

    Report

    Report Number
    3006942548-2025-00002
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    September 24, 2025
    Report Date
    November 21, 2025
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER STATEMENT: AFTER ARRIVAL OF THE CATHETER AT THE PLANT, IT WAS CHECKED IF THE SERIAL NUMBER OF THE RECEIVED CATHETER AND THE CATHETER DESCRIBED IN THE COMPLAINT FORM SENT BY THE CUSTOMER DO MATCH. THE REPORTED SERIAL NUMBER AND THE SERIAL NUMBER OF THE RECEIVED CATHETER MATCHED (PRODUCT 092946-001, SN: (B)(6)). IT WAS FURTHER INVESTIGATED IF THE MICROCHIP AND THE TITANIUM HOUSING SHOW ANY SIGNS OF MECHANICAL DAMAGE. NO DAMAGE ON THE SILICONE OR THE CHIP WAS FOUND. 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. AN INITIAL CHECKUP IN AIR AT ROOM TEMPERATURE WAS PERFORMED. THE CATHETER HAS SHOWN AN ICP VALUE OF 7.6 MMHG IN AIR AND A VALUE OF 6.8 MMHG IN 37 °C WATER BATH, WHICH IS OUT OF SPECIFICATION. HOWEVER, THIS ASPECT MUST BE CONSIDERED IN RELATION TO THE TRANSIENT BEHAVIOR (DESCRIBED BELOW). BECAUSE THE IMPLAUSIBLE ICP-VALUE, A TIGHTNESS TEST WAS CARRIED OUT TO CHECK WHETHER THE MEASURING WINDOW IS SEALED AGAINST AIR UND LIQUIDS. THEREFORE, THE CATHETER TIP WAS IMMERGED IN WATER AND A PRESSURE OF (310 +/-5 KPA) WAS APPLIED FROM THE SIDE OF THE CONNECTOR. IF AIR BUBBLES ARE VISIBLE, THE MEASURING WINDOW IS LEAKING. IN THIS INVESTIGATION NO AIR BUBBLES WERE FOUND. A LEAKAGE CAN BE EXCLUDED. ADDITIONALLY, THE PRESSURE SENSITIVITY WAS CHECKED. WITH A PRESSURE DIFFERENCE OF 10 MMHG, A CHANGE OF 9.8 MMHG COULD BE DETECTED, WHICH IS WITHIN SPECIFICATION. THE DIAGONAL RESISTANCES OF THE WHEAT STONE BRIDGE WERE MEASURED VIA THE MICRO WIRE CONTACTS ON THE PCB. THE SPECIFICATION FOR AN INTACT PRESSURE CHIP IS R = 2600 ± 600 OHM FOR EACH DIAGONAL; THE MEASURED VALUES WERE WITHIN SPECIFICATION (R1 = 2.31 KOHM / R2 = 2.85 KOHM). THE INPUT AND OUTPUT RESISTANCE (RA < 5KOHM, RE < 9 KOHM WERE INVESTIGATED. THE RESISTANCE VALUES (RE = 4.17 KOHM / RA = 2,62 KOHM) WERE WITHIN SPECIFICATION. TO CHECK THE ICP FUNCTION, A DRIFT TEST OVER 60H WAS PERFORMED. A PRESSURE DEVIATION OF 1.1 MMHG COULD BE DETECTED, WHICH IS WITHIN SPECIFICATION. A TRANSIENT BEHAVIOR AT THE BEGINNING OF THE DRIFT TEST COULD BE DETECTED. HOWEVER, SUCH TRANSIENT BEHAVIORS, ESPECIALLY AT THE BEGINNING OF THE MEASUREMENT, ARE NOT SPECIFIED. AFTER AROUND 2.5 H, A CONSTANT ICP VALUE COULD BE SHOWN, WHICH IS WITHIN SPECIFICATION. AFTERWARDS, AN EXTENDED DRIFT TEST WAS PERFORMED. THEREFORE, THE ICP VALUE WAS DETECTED DURING DIFFERENT TEMPERATURE AND PRESSURE (-40 TO 375 MMHG) PERIODS. THE ICP FUNCTION WAS NOT AFFECTED BY THE TEMPERATURE AND THE ICP SENSITIVITY WAS ALWAYS GIVEN. ADDITIONALLY, A DRIFT VALUE OF 0.4 MMHG COULD BE DETECTED, WHICH IS WITHIN SPECIFICATION. CONCLUSION: THE DESCRIBED ERROR (IMPLAUSIBLE HIGH ICP-VALUES (OVER 40 MMHG)) COULD NOT BE RECONSTRUCTED UNDER LABORATORY CONDITIONS. THE ICP-SENSITIVITY IS ALWAYS GIVEN, AND THE CATHETER RESPONDS WITHIN THE EXPECTED RANGE TO ICP-CHANGES. THIS CHARACTERISTIC COULD BE DEMONSTRATED BY A DYNAMIC DRIFT TEST. A TEMPERATURE RELATED MEASUREMENT ERROR IS EXCLUDED. THE DESCRIBED SITUATION (B. BRAUN SYSTEM SHOWED NORMAL ICP VALUES) COULD NOT BE RECONSTRUCTED BECAUSE THE B. BRAUN SYSTEM IS BASED ON A GENERALLY DIFFERENT MEASUREMENT SYSTEM COMPARED TO THE TIP CATHETER BY RAUMEDIC. ADDITIONALLY BASED ON THE INFORMATION SUPPLIED BY THE USER (THE CATHETER WAS IMPLANTED SUBDURAL), THE COMPLAINT IS HANDLED AS USER ERROR BECAUSE THE PRECAUTIONS AND INSTRUCTIONS ACCORDING TO SECTION 5 - OVERVIEW OF RAUMEDIC® PRECISION PRESSURE CATHETERS- OF THE INSTRUCTIONS FOR USE ZWO-013 WERE NOT SUFFICIENTLY OBSERVED. THE CATHETER IS INTENDED FOR APPLICATION IN THE PARENCHYMA.

    Description of Event or Problem · 0

    ON OCTOBER 23RD WE RECEIVED THE FOLLOWING INFORMATION FROM OUR DISTRIBUTOR IN TAIWAN: "THE ICP VALUE WAS FOUND WITH A RELATIVELY HIGH @ 6~7 MMHG IN THE AIR BEFORE CATHETER IMPLANTED. FOLLOWING WITH AN UNREALISTIC HIGH VALUE 40+ MMHG, BUT PATIENT ALL VITAL SIGN PRESENTED NORMAL. THE CATHETER WAS REPLACED BY B. BRAUN, ICP VALUE TURNED NORMAL, OR SAID IT'S CLOSER TO DR EXPECTATION. IMPLANTATION: (B)(6) 2025; EXPLANTATION: (B)(6) 2025; HEALTH STATUS OF THE PATIENT: HEALTHY AND DISCHARGED; ADDITIONAL OPERATION: PATIENT WAS UNDERGONE RE-DO SURGERY TO REPLACE OUR CATHETER BY B.BRAUN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925663 NEUROVENT-P NEUROLOGICAL CATHETER GWM RAUMEDIC AG 092946-001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention