BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROVENT-P

    MDR report key: 8572732 · Received May 2, 2019

    Report

    Report Number
    3006942548-2019-00002
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    April 9, 2019
    Report Date
    April 9, 2019
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    UDI-DI
    04057834026108
    PMA / PMN Number
    K103206
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER STATEMENT: FOR EVALUATION OF THE MALFUNCTION DHR DOCUMENTS WERE REVIEWED. THEY DEMONSTRATE THAT THE CATHETER NEUROVENT-P (SN (B)(4)) MET SPECIFICATION DURING MANUFACTURING. FINAL INSPECTION OF THE FINISHED CATHETER WAS PASSED. THIS DEMONSTRATES THAT THE CATHETER HAS BEEN MANUFACTURED AND SOLD IN CONFORMANCE TO RELEVANT SPECIFICATIONS. THE SALES REPRESENTATIVE WHO WAS AROUND DURING IMPLANTATION PROCEDURE CONFIRM INITIAL FUNCTIONALITY OF THE CATHETER. FURTHERMORE RETURNED CATHETER WAS INVESTIGATED. THIS INVESTIGATION DEMONSTRATES THAT ONE WIRE IS TORN OFF. BASED ON KNOWLEDGE ABOVE AND IN CONSIDERATION OF THE RESULTS OF PERFORMED INVESTIGATION OF RETURNED CATHETER, THE TEAR-OFF OF THE WIRE IS CAUSED BY USER ERROR BY STRETCHING OF THE CATHETER DURING APPLICATION CONTRARY TO IFU. THIS IS IN ACCORDING WITH THE DESCRIPTION OF THE CUSTOMER, THAT THE LOSS OF ICP OCCURRED DURING THE TRANSPORT TO THE ICU AFTER SUCCESSFUL IMPLANTATION IN THE OPERATING ROOM.

    Description of Event or Problem · 1

    SHORTLY AFTER SUCCESSFUL IMPLANTATION OF THE CATHETER ICP COULD NOT BE MONITORED ANYMORE. THE TROUBLESHOOTING SHOWED THAT NO MEASUREMENT WERE POSSIBLE WITH A DIFFERENT NPS2 OR NPS3. MASSAGE "PRESSURE SENSOR FAILURE" APPEARED ON THE MONITOR WHEN THE ZEROING PROCESS WERE DONE. A DEMO CATHETER WORKED FINE CONNECTING TO THE PATIENT MONITOR. THEREFORE THE DOCTOR TOOK THE PATIENT BACK TO THE OPERATING ROOM AND REPLACED THE CATHETER. THE HEALTH CONDITION OF THE PATIENT WAS NOT INFLUENCED BY THIS. CUSTOMER DESCRIBED THAT THE LOSS OF ICP SIGNAL OCCURRED DURING TRANSPORT TO ICU AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366019 NEUROVENT-P NEUROLOGICAL CATHETER GWM RAUMEDIC AG 092946-002 04057834026108

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention