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

Model Number	092946-002
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
From clinic (b)(6) we received information that an of raumedic catheter neurovent-p (sn (b)(4)) is reading an icp value of 222mmhg.The catheter were placed with tunneling sleeve.The icp readings were immediately high after implanting, so physican knew something was wrong.They tried to trouble shoot the catheter without success.The clinic decides to replaced catheter complained by another catheter.This was done in an additional surgery.The implantation did not alter the patients current health state.The issue with the catheter icp reading had no consequences for the health of the patient.
Additional Manufacturer Narrative
Manufacturer statement: for evaluation of the malfunction dhr documents were reviewed.They demonstrate that the catheter neurovent-p (sn (b)(4)) 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 showed a static value of 389.1 mmhg on the monitor which is clearly out of specification.The connector was opened and visually inspected to check if the pcb was exposed to moisture or a high pulling force.All wires of the micro cable were still connected to the soldering pads of the pcb and no residues of moisture could be detected.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 a damage on the silicone covering above the pressure chip was found.Those were located directly on the silicone layer and even reached the chip directly, which is considered as critical for correct catheter functionality.A subsequent visual inspection clearly shows deeper damaging directly at the chip itself.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.

• 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: 15417676
• Report Number: 3006942548-2022-00002
• Device Sequence Number: 11459478
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

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: 02/28/2025
• Device Model Number: 092946-002
• Device Catalogue Number: 092946-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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 Age: 1 YR
• Patient Sex: Male