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

Model Number 092946-001

Device Problems No Device Output (1435); Unable to Obtain Readings (1516)

Patient Problems Headache (1880); Convulsion/Seizure (4406)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

Summary of the event from the manufacturer's perspective and the investigations and interviews conducted: manufacturing documents of the corresponding sn (b)(6) were checked and found to be correct.The investigation of returned catheter revealed the main cause of the error message on the monitor based on a defective catheter.The error (failure of icp-display) of the complained catheter could be reconstructed under laboratory conditions.The visual inspection of the pcb showed clear signs of mechanical stress.Because the pull reserve was exhausted completely the catheter was mechanical stressed.During the high pulling force one wire of the pressure chip was pulled off the soldering pad.Therefore, the icp-measurement failed.Due to the present mechanical manipulation of the catheter, the precautions and instructions according to section 6 of the instructions for use zwo-013 were not sufficiently observed."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." - extract from section 6 instructions for use zwo-013 therefore, this complaint is handled as user error (see also attached evaluation summary).

Event Description

From our distributor we received on 03/04/2024 the following decription of an event to one of our catheter neurovent-p (sn (b)(6)): "we have a patient where error code po1 displayed on the monitor last night - monitor & cables changed and this did not resolve the issue.The probe was replaced and has worked fine overnight until the patient had a seizure and now po1 showing again.The probe has position at all since the seizure.Raumedic: p01 = der gemessene druck liegt ausserhalb der eingestellten grenzwerte check the self entered alarm limits on the device due to error code p01.Feedback from the hospital this morning is that they changed the probe and were able to monitor without issue following the new implant.The code po1 was seen despite cable changes and a monitor change.".

• Brand Name: NEUROVENT-P
• Type of Device: 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: 18985946
• MDR Text Key: 338696745
• Report Number: 3006942548-2024-00005
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 092946-001
• Device Catalogue Number: 092946-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male