BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROVENT-P

    MDR report key: 19413234 · Received May 29, 2024

    Report

    Report Number
    3006942548-2024-00006
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    April 1, 2024
    Report Date
    May 28, 2024
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY OF THE EVENT FROM THE MANUFACTURER'S PERSPECTIVE AND THE INVESTIGATIONS AND INTERVIEWS CONDUCTED: MANUFACTURING DOCUMENTS OF THE CORRESPONDING SN (B)(6) WERE CHECKED AND FOUND TO BE CORRECT. THE FURTHER INVESTIGATIONS OF THE NEUROVENT-P CATHETERS SHOW THAT THE CATHETERS PERFORM WITHIN SPECIFICATIONS. A PRODUCT FAILURE CAN BE EXCLUDED AS CAUSE. WITH REFERENCE TO THE USER'S DESCRIPTION OF THE COMPLAINT, THE USER DETERMINED A DRIFT DERIVATION IN AIR. IT SHOULD BE NOTED THAT A MEASUREMENT IN AIR CANNOT BE USED AS AN INDICATOR OF CATHETER DRIFT. A MEASUREMENT IN AIR IS NOT VALID FOR EVALUATING THE PERFORMANCE OF THE CATHETER SINCE IT DOES NOT REFLECT THE INDICATED CLINICAL CONDITIONS OF USE. ADDITIONALLY, A PLAUSIBILITY TEST OF THE ICP VALUE OF THE CATHETER IN AIR IS NOT INTENDED ACCORDING TO IFU. THEREFORE THIS COMPLAINT IS HANDLED AS USER ERROR. THE DESCRIBED ERROR (IMPLAUSIBLE HIGH ICP DRIFT) COULD NOT BE RECONSTRUCTED UNDER LABORATORY CONDITIONS (SEE ALSO ATTACHED EVALUATION SUMMARY).

    Description of Event or Problem · 0

    FROM OUR DISTRIBUTOR WE RECEIVED ON 05/03/2024 THE FOLLOWING DESCRIPTION OF AN EVENT TO CATHETER NEUROVENT-P (SN (B)(6) : "CUSTOMER COMMENTED "I NOTICED THAT ISSUE FOR LAST THREE/FOUR WEEKS AGO . IT WAS VERY ODD WE KEPT OPENING NEW PACK B/C ICP MONITOR WAS SHOWING DRIFTING MORE THAN TWO 3 ,I UNDERSTAND 1-2 MARGINALLY SEEM TO BE ACCEPTABLE ON AIR HOWEVER COUPLE OF PACK HAS SAME PROBLEM." THE HOSPITAL ARE CONCERNED AS THE PATIENT HAD TO HAVE MULTIPLE DEVICES IMPLANTED - NO OTHER DETAILS HAVE BEEN RELEASED BUT THIS WILL HAVE CAUSED A REPEATED PROCEDURE / LENGTHENED TREATMENT TIME. EXACT DATE OF THE IMPLANT / EXPLANT HAS NOT BEEN RELEASED BY THE HOSPITAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1838122 NEUROVENT-P NEUROLOGICAL CATHETER GWM RAUMEDIC AG 092946-001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention