BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROVENT-P

    MDR report key: 16885049 · Received May 8, 2023

    Report

    Report Number
    3006942548-2023-00006
    Event Type
    Injury
    Date Received
    May 8, 2023
    Date of Event
    October 19, 2021
    Report Date
    May 8, 2023
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER STATEMENT: SUMMARY OF THE EVENT FROM THE MANUFACTURER'S PERSPECTIVE AND THE INVESTIGATIONS AND INTERVIEWS CONDUCTED: THE CLINIC HAS DISPOSED OF THE CATHETER SO THAT IT IS NOT AVAILABLE FOR INVESTIGATIONS. THE SN IS UNKNOWN. A CHECK OF THE SERIAL NUMBERS OF ALL POSSIBLE NEUROVENT-P IN QUESTION DURING THE MANUFACTURING PERIOD SHOWED THAT ALL MANUFACTURING RECORDS DOCUMENT A PROPER DELIVERY CONDITION. FINAL INSPECTIONS OF THE FINISHED CATHETERS WERE PASSED. THIS DEMONSTRATES THAT THE CATHETERS HAVE BEEN MANUFACTURED AND SOLD IN CONFORMANCE TO RELEVANT SPECIFICATIONS. FROM THE CLINIC'S DESCRIPTION OF THE FACTS OF THE INCIDENT, IT IS CLEAR THAT THE NEUROVENT-P FUNCTIONED JUST AS CORRECTLY AFTER IMPLANTATION AND DISPLAYED THE SAME OR SIMILAR ICP VALUES AS THE NEUROVENT-PTO FOR WHICH IT WAS USED AS A SUBSTITUTE AND FOR WHICH THE RESULTS OF RAUMEDIC INVESTIGATIONARE NOW AVAILABLE WITH THE RESULT THAT IT DOES NOT EXHIBIT ANY MALFUNCTION. SUBSEQUENTLY RISING ICP VALUES CANNOT BE FURTHER ASSESSED BY RAUMEDIC AS TO THE REASONS FOR THIS (PHYSIOLOGICAL CAUSE COULD BE POSSIBLE). THE CLINIC ALSO REPORTED BLEEDING ALONG THE CATHETER, WHICH COULD ALSO BE THE CAUSE OF THE INDICATED INCREASE IN PRESSURE. EVEN IF WE ASSUME ON THE PART OF RAUMEDIC AND THE CIRCUMSTANCES DESCRIBED THAT THE CATHETER FUNCTIONED PROPERLY AT ALL TIMES, WE CANNOT EXCLUDE THE POSSIBILITY OF A MALFUNCTION, AS THE CATHETER WAS NOT MADE AVAILABLE BY THE CLINIC FOR INVESTIGATION. DUE TO THE DECISION OF CLINIC THAT THE PATIENT NEEDED ANOTHER CATHETER THIS IS CONSIDERED AS INTERVENTION AND THE EVENT IS THEREFORE ASSESSED AS SERIOUS INJURY. THERFORE THE EVENT IS REPORTABLE ACCORDING TO 21 CFR 803.50. NOTE: THE REPORTING OF THIS EVENT IS BASED ON OBSERVATION 1 DURING INSPECTION FROM 1/30/2023 - 2/2/2023 AND THEREFORE TAKES PLACE OUTSIDE THE 30-DAY REPORTING PERIOD.

    Description of Event or Problem · 0

    THROUGH OUR DISTRIBUTOR OF SWEDEN WE RECEIVED THE FOLLOWING DESCRIPTION OF AN EVENT TO ONE OF OUR CATHETER NEUROVENT-P (SN UNKNOWN) SENT OF CLINIC NORRLANDS UNIVERSITETSSJUKHUS, NKK : "UNEXPLAINED HIGH VALUES OF ICP WHEN IMPLANTING THE NEUROVENT PTO, I INITIALLY HAD ICP OF 11 WHICH WAS EXPECTED. WHEN THE OR-NURSE PUT ON THE BANDAGE, THE PRESSURE INCREASED TO 50, THEN TO 120. WE REMOVED THE BANDAGE AND THEN THE PRESSURE DROPPED TO 11 AGAIN - OTHERWISE THERE WAS NO EXPLANATION FOR THE INCREASE CLINICALLY. PATIENT WAS COMPLETELY STABLE AND NO CRAMPS ETC! THEN REPLACED THE NEUROVENT PTO WITH ANOTHER RAUMEDIC WITHOUT PTO, A NEUROVENT-P. IT ALSO WORKED FINE INITIALLY, BUT THEN ALSO THE ICP INCREASED TOWARDS 50, THEN THEY PUT IN A V-DRAIN THAT SHOWED ICP BETWEEN 10 AND 15. THEN THE NEUROVENT-P STOPPED REGISTERING ANY ICP AT ALL. BEFORE REMOVING IT, I TRIED SEVERAL TIMES TO UNSUCCESSFULLY ZEROING IT. CONNECTED IT TO THE MONITOR THAT COMES WITH RAUMEDIC (DATALOGGER) WHICH SHOWED ICP 7 - IT WAS A DRIFT OF 8 MMHG COMPARE TO THE V-DRAIN-REGISTERED ICP." THE FURTHER INFORMATION ON THIS EVENT ARE THE DESCRIPTIONS BELOW: THE EVENT HAS AFFECT THE HEALTH OF TH PATIENT: "A FURTHER CT WAS PERFORMED AND AN EVD WAS INSERTED." DUE TO THE EVENT AN ADDITIONAL MEDICINAL TREATMENT NECESSARY: "PAT RECEIVED BOLUS OF PROPOFOL AND MIDAZOLAM DUE TO INCORRECT ICP READINGS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877556 NEUROVENT-P NEUROLOGICAL CATHETER GWM RAUMEDIC AG 092946-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention