BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROVENT-P

    MDR report key: 16213050 · Received January 20, 2023

    Report

    Report Number
    3006942548-2023-00002
    Event Type
    Injury
    Date Received
    January 20, 2023
    Date of Event
    December 19, 2022
    Report Date
    February 10, 2023
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    UDI-DI
    04057834026108
    PMA / PMN Number
    K103206
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER STATEMENT: MANUFACTURING DOCUMENTS OF THE CORRESPONDING SN (B)(6) WERE ALREADY CHECKED AND FOUND TO BE CORRECT. FOR EVALUATION THE DHR DOCUMENTS WERE REVIEWED. THEY DEMONSTRATE THAT THE CATHETER NEUROVENT-P (SN (B)(6)) 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, SEE EVALUATION SUMMARY. AN INITIAL CHECKUP IN AIR AT ROOM TEMPERATURE WAS PERFORMED. THE CATHETER HAS SHOWN NO ICP VALUE WHATSOEVER. THE CONNECTOR WAS OPENED AND VISUALLY INSPECTED TO CHECK IF THE PCB WAS EXPOSED TO MOISTURE OR A HIGH PULLING FORCE. ALL FOUR WIRES WERE STILL CONNECTED TO THEIR RESPECTIVE SOLDERING PADS AND NO SIGNS OF MOISTURE COULD BE FOUND. ADDITIONALLY, THE PINS ON THE PLUG WERE CHECKED AND NO ABNORMALITIES WERE FOUND. IT WAS ALSO INVESTIGATED IF THE MICROCHIP SHOWS ANY SIGNS OF MECHANICAL DAMAGE. THE MEASUREMENT WINDOW WAS VISUALLY INSPECTED AND DAMAGE ON THE SILICONE COVERING ABOVE THE PRESSURE CHIP WAS FOUND. THOSE WERE LOCATED DIRECTLY ON THE SILICONE LAYER, WHICH IS CONSIDERED AS CRITICAL FOR CORRECT CATHETER FUNCTIONALITY. A SUBSEQUENT VISUAL INSPECTION CLEARLY SHOWS, THAT THE CHIP ITSELF WAS DAMAGED. THE CHIP WAS LIFTED FROM THE MEASUREMENT WINDOW AND A CRACK IN THE CHIP MEMBRANE IS ALSO VISIBLE ON THE BACK SIDE. THIS DAMAGE ON THE SILICONE COVER IS DUE TO MECHANICAL MANIPULATION WITH SURGICAL TOOLS AND THEREFORE, THIS INCIDENT IS HANDLED AS AN USER ERROR. THE INSTRUCTIONS FOR USE ZWO-013 ACCORDING TO SECTION 6 PRECAUTIONS WERE NOT 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. ALTHOUGH A USER ERROR THROUGH IMPROPER HANDLING OF THE PRODUCT COULD BE SHOWN AS THE CAUSE OF THE EVENT, THE EVENT IS REPORTABLE ACCORDING TO 21 CFR 803.50. THE PATIENT NEEDED ANOTHER CATHETER THIS IS CONSIDERED AS INTERVENTION AND THE EVENT IS THEREFORE ASSESSED AS SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    MANUFACTURER STATEMENT: MANUFACTURING DOCUMENTS OF THE CORRESPONDING SN (B)(4) WERE ALREADY CHECKED AND FOUND TO BE CORRECT. ACCORDING TO THE INITIAL IMPORTER, THE CATHETER IS ON ITS WAY TO RAUMEDIC. AS SOON AS THE CATHETER ARRIVED AT RAUMEDIC, COMPLETE ANALYSIS / FAULT INVESTIGATION OF THE DEVICE WILL BE CARRIED OUT.

    Description of Event or Problem · 0

    FROM (B)(6) WE RECEIVED ON 2022-12-19 THE FOLLOWING INFORMATION ABOUT OUR CATHETER NEUROVENT-P (SN (B)(6): "TODAY WE PLACED A RAUMEDIC ICP CATHETER AND THE SURGEONS WEREN'T ABLE TO GET A READING, AFTER ATTEMPTING TO FIX THE PROBLEM WITHOUT REMOVING THE CATHETER IT WAS DECIDED TO REPLACE THE CATHETER WITH A NEW ONE. UPON REPLACING THE CATHETER IT WORKED PERFECTLY." AFTER CONSULTATION OF THE CLINIC WE GET ADDITIONAL INFORMATION THAT THE CATHETER WERE PLACED WITH TUNNELING SLEEVE IN ACCORDANCE OT THE IFU. THE PATIENT RECEIVED A NEW CATHETER DONE AT BEDSIDE. THE SECOND CATHETER WORKED AS EXPECTED. THE EVENT HAD NO CONSEQUENCE ON THE PATIENT'S STATE OF HEALTH.

    Description of Event or Problem · 0

    FROM (B)(6) WE RECEIVED ON (B)(6) 2022 THE FOLLOWING INFORMATION ABOUT OUR CATHETER NEUROVENT-P (SN (B)(4)): "TODAY WE PLACED A RAUMEDIC ICP CATHETER AND THE SURGEONS WEREN'T ABLE TO GET A READING, AFTER ATTEMPTING TO FIX THE PROBLEM WITHOUT REMOVING THE CATHETER IT WAS DECIDED TO REPLACE THE CATHETER WITH A NEW ONE. UPON REPLACING THE CATHETER IT WORKED PERFECTLY." AFTER CONSOLATION OF THE CLINIC WE GET ADDITIONAL INFORMATION THAT THE CATHETER WERE PLACED WITH TUNNELING SLEEVE IN ACCORDANCE OT THE IFU. THE PATIENT RECEIVED A NEW CATHETER DONE AT BEDSIDE. THE SECOND CATHETER WORKED AS EXPECTED. THE EVENT HAD NO CONSEQUENCE ON THE PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363421 NEUROVENT-P NEUROLOGICAL CATHETER GWM RAUMEDIC AG 092946-002 04057834026108

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention