BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROVENT-IFD-R

    MDR report key: 8738409 · Received June 27, 2019

    Report

    Report Number
    3006942548-2019-00003
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    May 23, 2019
    Report Date
    May 31, 2019
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    UDI-DI
    04057834029338
    PMA / PMN Number
    K120252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER STATEMENT: FOR EVALUATION OF THE MALFUNCTION DHR DOCUMENTS WERE REVIEWED. THEY DEMONSTRATE THAT THE CATHETER NEUROVENT-IFD-R (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 DECISION OF THE CLINIC TO APPLICATE A SECOND ICP CATHETER TWO DAYS AFTER INITIAL APPLICATION OF THE N-IFD-R IS BASED ON THE FACT THAT THE N-IFD-R STOPPED WORKING BECAUSE OF INCORRECT HANDLING CONTRARY TO THE IFU SO ALL WIRES HAVE BEEN TORN OFF. IN ACCORDANCE TO THE IFU THE N-IFD-R HAS TO BE REMOVED LATEST AFTER 5 DAYS. EVENTUALLY THE IMPLANTATION PERIOD EXCEEDED UP TO 15 DAYS, IN WHICH THE LEAKAGE PROBLEM, AGAIN BASED ON INCORRECT HANDLING CONTRARY TO THE IFU, OCCURRED AFTER 13 DAYS OF IMPLANTATION, WHICH WE CONSIDER AS OFF LABEL USE. (B)(4).

    Description of Event or Problem · 1

    THE CLINIC PLACED AN ICP/DRAIN (N-IFD-R) ON (B)(6) 2019. THEN ON (B)(6) 2019 INACCURATE ICP VALUES WERE READING IN THE 70'S BUT ONLY STRAIGHT LINE NO WAVEFORM. ON (B)(6) 2019 AN EVD DRAIN WAS CONNECTED TO THE N-IFD-R, SO AN ICP MONITORING WAS POSSIBLE AND ALSO WAVEFORM AND READINGS OF 16-18 COULD BE MONITORED, WHICH IS WHAT PATIENT HAD BEEN READING PREVIOUSLY. ON (B)(6) 2019 THE CLINIC DECIDED TO APPLICATE ANOTHER ICP CATHETER TO OBTAIN ACCURATE CONTINUOUS ICP READINGS. LEFT THE N-IFD-R IN TO CONTINUE DRAINAGE. THEN ON (B)(6) 2019 THE EVD CONNECTION BETWEEN N-IFD-R AND EVD DRAIN CAME APART AND STARTED LEAKING CSF. THE CLINIC DECIDED THEY NEED TO ATTEMPT TO REPAIR THE LEAKAGE AS PHYSICIAN FELT HE WOULD NOT BE ABLE TO PLACE ANOTHER CATHETER BASED ON THE SIZE OF THE VENTRICLES. THE CLINIC STARTED PATIENT ON PROPHYLACTIC ANTIBIOTICS. ON (B)(6) 2019 THE CLINIC REMOVED THE SYSTEM N-IFD-R / EVD. PATIENT WOKE UP MOVING EXTREMITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532006 NEUROVENT-IFD-R NEUROLOGICAL CATHETER GWM RAUMEDIC AG 095317-002 04057834029338

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention