BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROVENT-IFD-S

    MDR report key: 22791199 · Received August 13, 2025

    Report

    Report Number
    3006942548-2025-00001
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 20, 2025
    Report Date
    August 12, 2025
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER STATEMENT: NO SERIAL NUMBER COULD BE RECORDED FOR THE CATHETER SENT BECAUSE THE PLUG WAS CUT OFF BY THE USER. HOWEVER, IT WAS CONFIRMED THAT IT WAS A NEUROVENT-IFD-S (091678-001). THE FOLLOWING CATHETERS WERE ASSIGNED TO THE HOSPITAL, SO THE CATHETER IN QUESTION BELONGS TO THE SN GROUP: DELIVERY DATE: (B)(6) 2025. SERIAL NUMBER: (B)(6).. NO ANOMALIES WERE IDENTIFIED IN THE CATHETER MANUFACTURING RECORDS. THE AVAILABLE CATHETER TIP SHOWED CLEAR SIGNS OF MECHANICAL STRESS. EXTENSIVE DAMAGE TO THE MAIN CATHETER WAS EVIDENT IN THE AREA OF THE DRAINAGE HOLES. FURTHERMORE, PRESSURE MARKS DUE TO A HARD STRUCTURE WERE IDENTIFIED ON THE CATHETER TUBE NEAR THE CATHETER HEAD. THE MICROCHIP AND THE TITANIUM HEADPIECE WERE ALSO EXAMINED FOR DAMAGE. NO SIGNS OF MECHANICAL STRESS WERE DETECTED ON THE TITANIUM HEADPIECE. THE CATHETER SHOWED CLEAR SIGNS OF SEVERE MECHANICAL DAMAGE DUE TO THE APPLICATION OF FORCE (TENSION). SINCE THE CATHETER WAS APPLIED AS INTENDED USING THE BOLT CH9, THE FIT OF THE CATHETER AND BOLT CH9 IS ENSURED. THIS CONCLUDES THAT THE FOLLOWING SECTIONS OF THE INSTRUCTIONS FOR USE ZWO-013DE REV. 32 WERE NOT SUFFICIENTLY OBSERVED: SECTION 6 - PRECAUTIONARY MEASURES / NOTES: "PRIOR AND DURING THE EXAMINATION, THE PRESSURE CATHETER MUST NOT BE BENT, STRETCHED OR SQUEEZED AS WELL AS MANIPULATED BY SURGICAL TOOLS." "IT MUST BE INSURED WITH APPLICATION THAT THE SENSOR CAN BE REMOVED WITHOUT PROBLEMS WITH A SLIGHT PULL." "EXTREME PULL OR DAMAGE TO THE CATHETER WITH SHARP INSTRUMENTS HAS TO BE AVOIDED - IN PARTICULAR DURING REMOVAL. CHECK FOR COMPLETENESS AFTER HAVING REMOVED THE CATHETER." SECTION 10 - MAKING ADRILL HOLE: "CAUTION: THE OPERATING AREA MUST BE FREED FROM BONE SPLINTERS OR TREATMENT RESIDUE AFTER EVERY DRILLING PROCESS OR ANY WORK ON THE DRILL HOLE (E.G. SHAPING A RAMP) WITH RINSING. POSSIBLY EXISTING BURRS AT THE BASE OF THE DRILL HOLE MUST BE REMOVED CAREFULLY." DUE TO THE CLEAR SIGNS OF MECHANICAL STRESS, THE DAMAGE DURING EXPLANTATION MUST HAVE BEEN CAUSED BY JAMMED BONE EDGES AND FORCES APPLIED TO THE CATHETER. THERE WAS NOT COMPLAINT ABOUT THE ICP-FUNCTION. THEREFORE, THE COMPLAINT WAS ASSESSED AS USER ERROR.

    Description of Event or Problem · 0

    ON JULY 28TH WE RECEIVED THE FOLLOWING ORAL INFORMATION FROM THE (B)(6): "THE NEUROVENT IFD-S WAS IMPLANTED VIA THE BOLT. THE EXPLANTATION COULD NOT BE PERFORMED AS USUAL. ACCORDING TO THE USER, THE CATHETER WAS STUCK IN THE BURR HOLE. AN ADDITIONAL SURGERY WAS NECESSARY TO EXPLANT THE CATHETER. BONE SPLINTERS, WHICH COULD HAVE CAUSED THE JAMMING, WERE NOT SEEN IN CT IMAGES. THE CATHETER TIP HAS BEEN SECURED AND IS AVAILABLE FOR INSPECTION. AN ADDITIONAL OPERATION INCLUDING ANESTHESIA WAS REQUIRED TO EXPLANT THE CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624324 NEUROVENT-IFD-S NEUROLOGICAL CATHETER GWM RAUMEDIC AG 091678-001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention