MAUDE Adverse Event Report: RAUMEDIC AG NEUROVENT-P; NEUROLOGICAL CATHETER

Model Number	092946-002
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: NEUROVENT-P
• Common Device Name: NEUROLOGICAL CATHETER
• Manufacturer (Section D): RAUMEDIC AG; am mühlgraben 10; zwönitz, 08297 ; GM 08297
• Manufacturer (Section G): RAUMEDIC AG; am mühlgraben 10; zwönitz, 08297 ; GM 08297
• Manufacturer Contact: hannes engelhardt ; am muehlgraben 10; zwoenitz, 08297 ; GM 08297
• MDR Report Key: 16213050
• Report Number: 3006942548-2023-00002
• Device Sequence Number: 4152426
• Product Code: GWM
• UDI-Device Identifier: 04057834026108
• UDI-Public: 04057834026108
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K103206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 092946-002
• Device Catalogue Number: 092946-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown