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

Model Number 095008-001

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  malfunction  

Event Description

From our distributor we received on 02/15/2024 the following information regarding a catheter neurovent-pto (095008-001) : the oxygen value during a continous monitoring didn't work.A ct was performed to check the catheter collacation, which was right.Instraction were given the neurosurgeon to open the screw and turn the probe accordingly the catheter was removed as the very same day the event did not affect the health status of the patient, no additional surgery or medical treatment were necessary.

Manufacturer Narrative

Manufacturer statement: on 02/27/2024, it became known that the catheter complained about was no longer available for investigation purposes.A review of the production documents shows that the catheter was manufactured and delivered in accordance with the specifications.Although a malfunction during application cannot be ruled out with absolute certainty, it must be taken into account that the ptio2 value is a secondary, non-vital parameter that only provides supplementary information.Against this background, a failure of the ptio2 measurement function could not in principle have led to a serious deterioration in the state of health, even if the error pattern would occur again (no malfunction recur).

• Brand Name: NEUROVENT-PTO
• 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: 18901589
• MDR Text Key: 337800862
• Report Number: 3006942548-2024-00004
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 095008-001
• Device Catalogue Number: 095008-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2023
• 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