BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROVENT-P

    MDR report key: 11858875 · Received May 20, 2021

    Report

    Report Number
    3006942548-2021-00003
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 4, 2021
    Report Date
    May 20, 2021
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER STATEMENT: SINCE ONLY THE CATHETER TIP (SENSOR HOUSING) WAS PROVIDED BY THE CLINIC FOR EXAMINATION PURPOSES, ONLY A VISUAL INSPECTION COULD BE PERFORMED. SCRATCHES SHOW THAT THE CATHETER HEAD WAS SUBSEQUENTLY REMOVED WITH METALLIC OBJECTS. IT WAS ALSO NOT POSSIBLE TO CHECK THE MANUFACTURING RECORDS, AS NO SERIAL NUMBER WAS PROVIDED. HOWEVER, IT CAN BE ASSUMED THAT THE CATHETER WAS MANUFACTURED PROPERLY, SINCE IT WAS RELEASED FOR DISTRIBUTION AND THE CATHETER WAS USED IN A FUNCTIONALLY CORRECT MANNER BEFORE THE EXPLANATION. THE USER'S COMPLAINT REPORT SHOWS THAT THE CATHETER TIP GOT STUCK ON THE INSIDE OF THE SKULL BONE DURING EXPLANTATION AND TORE OFF UNDER FURTHER TRACTION AND ROTATION. IT WAS ALSO REPORTED THAT THE SUBSEQUENT CT SCAN SHOWED THAT THE PERFORATION OF THE SKIN AND THE BONE CANAL WERE NOT DIRECTLY ON TOP OF EACH OTHER, SO THERE MAY HAVE BEEN SHEAR FORCES HERE. NO PRODUCT DEFECT IS SUSPECTED. THIS INFORMATION WAS CONFIRMED ON REQUEST BY OUR SALES FIELD REPRESENTATIVE. IN THE FOLLOWING THE EXCERPT FROM RELATED E-MAIL DATED 04.05.2021: "HELLO, I HAD JUST RECEIVED FEEDBACK FROM MY CONTACT DR (B)(6) FROM (B)(6). HE TOOK A CLOSE LOOK AT THE PICTURES FROM BEFORE THE EXPLANTATION. THE DRILL HOLE THROUGH THE SKULL BONE IS DISPLACED BY ABOUT 1CM RELATIVE TO THE SKIN OPENING. PRESUMABLY, AND ACCORDING TO HIM THIS HAPPENS MORE OFTEN, THAT THE DRILL "RAN AWAY" ON THE BONE. "THE NEUROVENT-P IN (B)(6) IS PLACED USUALLY PERCUTANEOUSLY. FOR THIS PURPOSE, THE DRILL HOLE DIAMETER OF 4.5 MM, WHICH WAS ALSO USED HERE, IS COMPLETELY SUFFICIENT BECAUSE THE CATHETER IS PULLED OUT OF THE DRILL HOLE VERTICALLY. HOWEVER, DUE TO THE ERROR DURING DRILLING, A TUNNEL OF APPROX. 1CM LENGTH WAS CREATED WITH A KINKING OF THE NEUROVENT-P BY APPROX. 90°. THIS WAS APPARENTLY NOT ADEQUATELY CONTROLLED BEFORE EXPLANTATION. WHEN THE CATHETER WAS PULLED OUT, THE CATHETER HEAD GOT STUCK ON THE BONE FLAP AND GOT RIPPED OFF." SINCE THE CATHETER MUST HAVE MET INTERNAL TENSILE AND STRENGTH SPECIFICATIONS DURING MANUFACTURE, THIS IS CONSIDERED AS AN APPLICATION ERROR DUE TO IMPROPER HANDLING DURING EXPLANTATION. THE PRECAUTIONS AND INSTRUCTIONS ACCORDING TO SECTION 6 AND 10 "PRECAUTIONS" OF THE INSTRUCTIONS FOR USE ZWO-013 WERE NOT SUFFICIENTLY OBSERVED. NOTE: THE ATTACHED EVALUATION SUMMARY CONTAINS THE SIGNED VERSION IN GERMAN AND A TRANSLATION INTO ENGLISH.

    Description of Event or Problem · 0

    ON 26TH OF APRIL 2021 THE NATIONAL AUTHORITY (B)(6) CONTACTED RAUMEDIC RELATING TO A REPORTING ON A RAUMEDIC CATHETER NEUROVENT-P WITH THE THE FOLLOWING INFORMATION: STATEMENT OF THE CLINIC FOR THE EVENT: - " DESCRIPTION OF THE EVENT FROM THE BFARM REPORT: ATTEMPT TO REMOVE PROBE: ON (B)(6) 2021, IN THE PROCESS THE TIP OF THE PROBE HAD STUCK ON THE INSIDE OF THE SKULL BONE AND TORE OFF DUE TO FURTHER TRACTION AND ROTATION. THE PART THAT REMAINED IN THE BODY WAS THEN REMOVED THROUGH SURGERY ON THE SAME DAY AND IS AVAILABLE FOR EXAMINATION. FURTHERMORE, THE CT SCAN SHOWED THAT THE PERFORATION OF THE SKIN AND THE BONE CANAL WERE NOT DIRECTLY ON TOP OF EACH OTHER, SO THAT SHEAR FORCES MAY HAVE OCCURRED HERE. NO PRODUCT DEFECT IS SUSPECTED. THE SURGERY PROCEEDED WITHOUT DAMAGE/COMPLICATIONS. THERE IS NO PERMANENT DAMAGE EVIDENT / PATIENT HAS NO PERMANENT CONSEQUENCES AS A RESULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757279 NEUROVENT-P NEUROLOGICAL CATHETER GWM RAUMEDIC AG 092946-001

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention