BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROVENT-P-TEMP

    MDR report key: 10387820 · Received August 10, 2020

    Report

    Report Number
    3006942548-2020-00004
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    July 8, 2020
    Report Date
    July 13, 2020
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER STATEMENT: FOR EVALUATION OF THE MALFUNCTION DHR DOCUMENTS WERE REVIEWED. THEY DEMONSTRATE THAT THE CATHETER NEUROVENT-P-TEMP (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. FURTHERMORE THE RETURNED CATHETER WAS INVESTIGATED. THE DESCRIBED BEHAVIOR OF SHOWING NEGATIVE ICP PRESSURE VALUES COULD RECREATED. THE RESULTS OF THE PRESSURE SENSITIVITY TEST DEMONSTRATE THAT THE CATHETER IS STILL MEASURING IN A PROPER WAY, DESPITE THE OFFSET. THE VISUAL TEST OF THE MEASUREMENT WINDOW HAS SHOWN, THAT THE SILICONE LAYER OVER THE MICROCHIP WAS CROOKED. THIS EXPLAINS THE DESCRIBED OFFSET. THIS DEFORMATION COULD BE CAUSED BY A HIGH MECHANICAL FORCE APPLIED ON THE SILICONE COVER OVER THE MICROCHIP. TO EXCLUDE ANY FURTHER POSSIBLE REASON FOR THIS OFFSET, IT WAS INNSIGATED IF ANY MECHANICAL FORCES WERE APPLIED ON THE CABLE LUMEN. THE CATHETER DID'NT SUFFER ANY, AS CLARIFIED IN THE TIGHTNESS TEST. THE RESULTS OF THE ANALYSIS INDICATE A USER ERROR, SINCE PRECAUTIONARY MEASURES AND NOTES ACC. SECTION 6 OF THE INSTRUCTIONS FOR USE ZWO-013 HAVE NOT BEEN SUFFICIENTLY OBSERVED. PRECAUTION: THE PRECISION PRESSURE CATHETERS ARE PRECISION MEASURING INSTRUMENTS AND SHOULD BE TREATED ACCORDINGLY. PRECAUTION: PRIOR AND DURING THE EXAMINATION, THE PRESSURE CATHETER MUST NOT BE BENT, STRETCHED OR SQUEEZED AS WELL AS MANIPULATED BY SURGICAL TOOLS.

    Description of Event or Problem · 1

    AFTER IMPLANTATION OF THE CATHETER NEUROVENT-P-TEMP ON (B)(6) 2020 THE ICP SIGNAL SHOWED INITIALLY UNDERSTANDABLE ICP VALUES AND A GOOD CURVE. AFTER 12 HOURS THE VALUES WERE INTERMITTENTLY AND AFTER 26 HOURS ONLY NEGATIVE. THE ICP CURVE WERE STILL WELL BUT BELOW ZERO. DESPITE ZERO ADJUSTMENT AND LOOSENING THE BOLT NO CHANGE. ON (B)(6) 2020 THE CLINIC DECIDED TO REPLACE THE CATHETER USING THE SAME BOREHOLE (SAME BOLT). THE NEW CATHETER WORKED FINE, THE VALUES RETURNED TO NORMAL. ACCORDING TO THE CLINIC THE HEALTH CONDITION OF THE PATIENT WAS NOT INFLUENCED BY THIS. THE CLINIC DECIDED AN ADDITIONAL SURGERY WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848372 NEUROVENT-P-TEMP NEUROLOGICAL CATHETER GWM RAUMEDIC AG 094268-001

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention