BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROVENT-PTO

    MDR report key: 16102024 · Received January 5, 2023

    Report

    Report Number
    3006942548-2023-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 2, 2022
    Report Date
    February 20, 2023
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER STATEMENT: MANUFACTURING DOCUMENTS OF THE CORRESPONDING SN E8320290 WERE ALREADY CHECKED AND FOUND TO BE CORRECT. THE CATHETER ARRIVED AT RAUMEDIC, COMPLETE ANALYSIS / FAULT INVESTIGATION OF THE DEVICE WILL BE CARRIED OUT.

    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. SINCE THE TEMPERATURE VALUES WERE COMPLAINED THE CATHETER WAS MEASURED AT ROOM TEMPERATURE AND IN A WATER BATH SET TO 37°C. THE CATHETER HAS SHOWN A TEMPERATURE VALUE 31,95°C ON AIR AT ROOM TEMPERATURE AND A VALUE OF 43,52°C IN A 37°C WATER BATH, WHICH IS OUT OF SPECIFICATION. THE CONNECTOR WAS OPENED AND VISUALLY INSPECTED TO CHECK IF THE PCB WAS EXPOSED TO MOISTURE OR IF THE CATHETER WAS SUBJECTED TO HIGH PULLING FORCE. BOTH THERMISTOR 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 (BLOOD, MOISTURE RESIDUES, BENT PINS) WERE FOUND. IT WAS FURTHER INVESTIGATED IF THE TITANIUM TIP SHOWS ANY SIGNS OF MECHANICAL DAMAGE. ADDITIONALLY, THE MEASUREMENT WINDOW WAS VISUALLY INSPECTED. NO DAMAGE ON THE SILICONE OR THE CHIP WAS FOUND. TO VERIFY THE CORRECT FUNCTIONALITY OF THE PTIO2 MEASUREMENT THE CATHETER WAS PUT IN A SOLUTION WITH 0% OXYGEN AND A VENTILATED WATER BATH. THIS MEASUREMENT SHOWED THAT THE CATHETER MEASURED A VALUE OF 7,4 MMHG AT 0%, WHICH IS OUT OF SPEC AND A VALUE OF 156,8 MMHG WHICH IS WITHIN SPEC. THIS SUGGESTS A LEAKAGE AT THE TIP OF THE OXYGEN FIBER IN THE BORE IT IS GLUED IN. TO CONFIRM ANY LEAKAGE THE CATHETER WAS CONNECTED TO A PUMP AND PRESSURE WAS APPLIED VIA THE CONNECTOR. AN AIR BUBBLE BEGAN TO FORM WHILE THE PRESSURE WAS APPLIED. THIS CONFIRMS A MICRO AIR CHANNEL LOCATED NEAR THE FIBER OPTIC AN EXPLAINS THE HIGHER PTIO2 VALUE AT 0% OXYGEN. DUE TO THE LEAKAGE MORE OXYGEN IS AVAILABLE AT THE FIBER OPTIC AND THEREFORE A HIGHER VALUE IS MEASURED. THIS EFFECT IS NOT VISIBLE AT 100% OXYGEN SATURATION. TO FINALIZE THE TECHNICAL ANALYSIS THE THERMISTOR WAS REMOVED FROM THE CATHETER AND VISUALLY INSPECTED AND NO DAMAGE OR CONTAMINATION WAS FOUND. THE DESCRIBED ERROR OF SHOWING AN IMPLAUSIBLE TEMPERATURE AND TOO HIGH PTIO2 VALUE COULD BE RECREATED UNDER LABORATORY CONDITIONS. THE LATTER IS CAUSED BY A LEAKAGE AS DESCRIBED ABOVE. THIS NON-INTENDED LEAKAGE MAY CAUSE MORE MOISTURE TO COLLECT INSIDE THE CATHETER. THIS HIGHER THAN USUAL MOISTURE CAN NEGATIVELY AFFECT THE FUNCTIONALITY OF THE THERMISTOR OVER A LONG PERIOD OF TIME. THE ISSUE OF MICRO-LEAKAGES AROUND THE OPTICAL FIBER IN THE TIP HOUSING WAS ALREADY ADDRESSED VIA CAPA, THERE THE FMEA WAS ALREADY EDITED. THE CATHETER WAS MANUFACTURED BEFORE THIS CAPA WAS SET TO BE EFFECTIVE.

    Description of Event or Problem · 0

    FROM OUR DISTRIBUTOR WE RECEIVED ON 5/12/2022 THE INFORMATION ABOUT AN EVENT REGARDING CATHETER NEUROVENT-PTO SN (B)(4). THE FOLLOWING IS THE ORIGINAL DESCRIPTION OF THE INCIDENT: "DÉFAUT DE SIGNAL DE LA TEMPÉRATURE AFFICHANT DES VALEURS AUX ALENTOURS DE 40°C ALORS QUE LE PATIENT ÉTAIT APYRÉTIQUE (CF. LES SONDES VÉSICALE ET OESOPHAGIENNE) ET DÉFAUT DE LA VALEUR DE LA PTIO2 ANORMALEMENT HAUTE PENDANT LE SÉJOUR, A L'ABLATION, ELLE ÉTAIT DE 120 ALORS QU'AVEC LA P ATMOSPHÉRIQUE, LA VALEUR DEVRAIT ÊTRE À 160. US TRANSLATION: "TEMPERATURE SIGNAL DEFECT SHOWING VALUES AROUND 40°C WHILE THE PATIENT WAS APYRETIC (CF. BLADDER AND ESOPHAGEAL PROBES) AND DEFECT OF THE PTIO2 VALUE ABNORMALLY HIGH DURING THE STAY, AT THE ABLATION, IT WAS 120 WHILE WITH THE ATMOSPHERIC P, THE VALUE SHOULD BE AT 160. CLERMONT FERRAND UNIVERSITY HOSPITAL HAS INFORMED US VIA THE DISTRIBUTOR THAT THEY HAVE AN ISSUE WITH OUR CATHETER NEUROVENT-PTO: TEMPERATURE AROUND 40°C WHILE THE PATIENT WAS APYRETIC AND PTIO2 VALUE ABNORMALLY HIGH. FURTHER INFORMATION WERE THE FOLLOWING : NO ELECTIVE MEASUREMENT. BOLT AND DRILL PTO WERE USED. CATHETER WAS NOT REPLACED. DURA WAS NOT OPENED WITH A SCALPEL. PATIENT CONDITION: "IN GOOD HEALTH". INTERVENTION HAD NO EFFECT ON THE PATIENT'S STATE OF HEALTH. NO FURTHER SURGERY OR MEDICINE WERE REQUIRED. ADDITIONAL MONITORING FOR ICP MEASUREMENT WAS USED: BLADDER AND OESOPHAGEAL CORE TEMPERATURE.

    Description of Event or Problem · 0

    FROM OUR DISTRIBUTOR WE RECEIVED ON 5/12/2022 THE INFORMATION ABOUT AN EVENT REGARDING CATHETER NEUROVENT-PTO SN (B)(6). THE FOLLOWING IS THE ORIGINAL DESCRIPTION OF THE INCIDENT: "DÉFAUT DE SIGNAL DE LA TEMPÉRATURE AFFICHANT DES VALEURS AUX ALENTOURS DE 40°C ALORS QUE LE PATIENT ÉTAIT APYRÉTIQUE (CF. LES SONDES VÉSICALE ET OESOPHAGIENNE) ET DÉFAUT DE LA VALEUR DE LA PTIO2 ANORMALEMENT HAUTE PENDANT LE SÉJOUR, A L'ABLATION, ELLE ÉTAIT DE120 ALORS QU'AVEC LA P ATMOSPHÉRIQUE, LA VALEUR DEVRAIT ÊTRE À 160. US TRANSLATION: "TEMPERATURE SIGNAL DEFECT SHOWING VALUES AROUND 40°C WHILE THE PATIENT WAS APYRETIC (CF. BLADDER AND ESOPHAGEAL PROBES) AND DEFECT OF THE PTIO2 VALUE ABNORMALLY HIGH DURING THE STAY, AT THE ABLATION, IT WAS120 WHILE WITH THE ATMOSPHERIC P, THE VALUE SHOULD BE AT 160. (B)(6) HOSPITAL HAS INFORMED US VIA THE DISTRIBUTOR THAT THEY HAVE AN ISSUE WITH OUR CATHETER NEUROVENT-PTO: TEMPERATURE AROUND 40°C WHILE THE PATIENT WAS APYRETIC AND PTIO2 VALUE ABNORMALLY HIGH. FURTHER INFORMATION WERE THE FOLLOWING : NO ELECTIVE MEASUREMENT; BOLT AND DRILL PTO WERE USED; CATHETER WAS NOT REPLACED; DURA WAS NOT OPENED WITH A SCALPEL; PATIENT CONDITION: "IN GOOD HEALTH; INTERVENTION HAD NO EFFECT ON THE PATIENT'S STATE OF HEALTH; NO FURTHER SURGERY OR MEDICINE WERE REQUIRED; ADDITIONAL MONITORING FOR ICP MEASUREMENT WAS USED: BLADDER AND OESOPHAGEAL CORE TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723667 NEUROVENT-PTO NEUROLOGICAL CATHETER GWM RAUMEDIC AG 095008-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention