BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROVENT-PTO

    MDR report key: 16937616 · Received May 16, 2023

    Report

    Report Number
    3006942548-2023-00007
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    March 30, 2023
    Report Date
    June 13, 2023
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 THE DESCRIBED ERROR PATTERN, NO TEMPERATURE AND TOO HIGH PTIO2 VALUE. WE HAVE MADE THE INITIAL CHECK-UP AND MEASURED O2 AT 100% AND 0%. FOR BOTH, THE CATHETER MEASURES PTIO2 VALUE, OUT OF SPECIFICATION. CONSULTATION WITH THE HOSPITAL SHOWED THAT THE APPLICATION WAS CARRIED OUT CONTRARY TO THE INSTRUCTIONS IN THE IFU. THE PTO CATHETER WAS TUNNELLED. THE INTENDED SKULL SCREW (BOLT KIT PTO) WAS NOT USED. THE HOSPITAL WAS ADVISED TO USE THE BOLT KIT PTO OR TO USE OUR NEUROVENT-PTO 2L PRODUCT FOR TUNNELLING. MONITORING OF THE PATIENT WAS POSSIBLE OVER THE ENTIRE DURATION WITH PERMANENT CONCLUSIVE ICP VALUES. NO FOLLOW-UP MEASURES WERE NECESSARY. THE COMPLAINED ABOUT CATHETER IS AVAILABLE FOR EXAMINATION PURPOSES. WE ARE CURRENTLY INVESTIGATING WHETHER THERE WAS A MALFUNCTION OR WHETHER THE FAILURE OF THE MEASURING FUNCTIONS IS RELATED TO THE WRONG APPLICATION. A FINAL INVESTIGATION REPORT IS NOT YET AVAILABLE AT THIS TIME. UPDATE DATED 2023-06-12: THE CONNECTOR WAS OPEND AND VISUALLY INSPECTED TO CHECK IF THERE IS ANY EVIDENCE OF POLLUTION, MOISTURE OR HIGH PULLING FORCE ON THE PCP. NO DEFECTS WERE DETECTED. ALL WIRES WERE STILL CONNECTED TO THE SOLDERING PADS AND NO SIGNS OF MOISTURE COULD BE FOUND. THE WIRE LOOP WAS UNDAMAGED AND INTACT. ADDITIONALLY, THE PINS ON THE PLUG WERE CHECKED. NO ABNORMALITIES WERE FOUND. FURTHERMORE, NO DAMAGE OF THE MEASURING HEAD WAS VISIBLE. THEREFORE, FURTHER INVESTIGATIONS WERE CARRIED OUT. ACCORDING TO THE INVESTIGATION REPORT DATED (B)(6) 2023, THE FAILURE OF THE MEASURING FUNCTIONS O2 AND TEMPERATURE WAS DUE TO THE USER ERROR. CONCLUSION: THE DESCRIBED ERROR COULD BE CONFIRMED IN LABORATORY CONDITIONS. THE CAUSE OF THER FAILURE IS AN EXCESSIVE BENDING OF THE CATHETER DUE TO IMPROPER USE DURING THE TUNNELING. THIS CAUSED DAMAGES TO THE COATING OF THE O2 FIBRE AND THERMISTOR WIRES. THEREFORE, THIS FAILURE IS CONSIDERED AS A HANDLING ERROR ON PART OF THE USER BECAUSE THE PRECATIONS AND INTRODUCTIONS ACCORDING TO SECTION 6 OF INSTRUCTION FOR USE ZWO-013 WERE NOT SUFFICIENTLY OBSERVED.

    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 THE DESCRIBED ERROR PATTERN, NO TEMPERATURE AND TOO HIGH PTIO2 VALUE. WE HAVE MADE THE INITIAL CHECK-UP AND MEASURED O2 AT 100% AND 0%. FOR BOTH, THE CATHETER MEASURES PTIO2 VALUE, OUT OF SPECIFICATION. CONSULTATION WITH THE HOSPITAL SHOWED THAT THE APPLICATION WAS CARRIED OUT CONTRARY TO THE INSTRUCTIONS IN THE IFU. THE PTO CATHETER WAS TUNNELLED. THE INTENDED SKULL SCREW (BOLT KIT PTO) WAS NOT USED. THE HOSPITAL WAS ADVISED TO USE THE BOLT KIT PTO OR TO USE OUR NEUROVENT-PTO 2L PRODUCT FOR TUNNELLING. MONITORING OF THE PATIENT WAS POSSIBLE OVER THE ENTIRE DURATION WITH PERMANENT CONCLUSIVE ICP VALUES. NO FOLLOW-UP MEASURES WERE NECESSARY. THE COMPLAINED ABOUT CATHETER IS AVAILABLE FOR EXAMINATION PURPOSES. WE ARE CURRENTLY INVESTIGATING WHETHER THERE WAS A MALFUNCTION OR WHETHER THE FAILURE OF THE MEASURING FUNCTIONS IS RELATED TO THE WRONG APPLICATION. A FINAL INVESTIGATION REPORT IS NOT YET AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    ON 04/19/2023, WE RECEIVED THE FOLLOWING REPORT BY TELEPHONE FROM (B)(6)HOSPITAL: "NEUROVENT-PTO CATHETER WAS PLACED WITHOUT BOLT-DRILL SET PTO. (NO DRILL TIP, NO DURA PERFORATOR, NO PEEK SCREW IMPLANT USED). APPROX. 6 HOURS AFTER IMPLANTATION OF THE PTO CATHETER. THE TEMPERATURE DISPLAY FAILED AND AS A RESULT THE PTIO2 PRESSURE DISPLAY FAILED. ICP VALUE WAS PRESENT WITH A CONCLUSIVE VALUE. CATHETER WAS CAREFULLY SEWN TO THE HEAD RIND. ALL CABLES REPLACED, NO IMPROVEMENT. PTO CATHETER. WAS IN PAT. UP TO APPROX. 18.04.23, ICP VALUE WAS PERMANENTLY AVAILABLE WITH A CONCLUSIVE VALUE." CONSULTATION WITH THE HOSPITAL SHOWED THAT THE APPLICATION WAS CARRIED OUT CONTRARY TO THE INSTRUCTIONS IN THE IFU. THE PTO CATHETER WAS TUNNELLED. THE INTENDED SKULL SCREW (BOLT KIT PTO) WAS NOT USED. THE HOSPITAL WAS ADVISED TO USE THE BOLT KIT PTO OR TO USE OUR NEUROVENT-PTO 2L PRODUCT FOR TUNNELLING. MONITORING OF THE PATIENT WAS POSSIBLE OVER THE ENTIRE DURATION WITH PERMANENT CONCLUSIVE ICP VALUES. NO FOLLOW-UP MEASURES WERE NECESSARY.

    Description of Event or Problem · 0

    ON (B)(6) 2023,WE RECEIVED THE FOLLOWING REPORT BY TELEPHONE FROM (B)(6) HOSPITAL: "NEUROVENT-PTO CATHETER WAS PLACED WITHOUT BOLT-DRILL SET PTO. (NO DRILL TIP, NO DURA PERFORATOR, NO PEEK SCREW IMPLANT USED). APPROX. 6 HOURS AFTER IMPLANTATION OF THE PTO CATHETER. THE TEMPERATURE DISPLAY FAILED AND AS A RESULT THE PTIO2 PRESSURE DISPLAY FAILED. ICP VALUE WAS PRESENT WITH A CONCLUSIVE VALUE. CATHETER WAS CAREFULLY SEWN TO THE HEAD RIND. ALL CABLES REPLACED, NO IMPROVEMENT. PTO CATHETER. WAS IN PAT. UP TO APPROX. 18.04.23, ICP VALUE WAS PERMANENTLY AVAILABLE WITH A CONCLUSIVE VALUE.". CONSULTATION WITH THE HOSPITAL SHOWED THAT THE APPLICATION WAS CARRIED OUT CONTRARY TO THE INSTRUCTIONS IN THE IFU. THE PTO CATHETER WAS TUNNELLED. THE INTENDED SKULL SCREW (BOLT KIT PTO) WAS NOT USED. THE HOSPITAL WAS ADVISED TO USE THE BOLT KIT PTO OR TO USE OUR NEUROVENT-PTO 2L PRODUCT FOR TUNNELLING. MONITORING OF THE PATIENT WAS POSSIBLE OVER THE ENTIRE DURATION WITH PERMANENT CONCLUSIVE ICP VALUES. NO FOLLOW-UP MEASURES WERE NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556149 NEUROVENT-PTO NEUROLOGICAL CATHETER GWM RAUMEDIC AG 095008-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male