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

Model Number 092946-001

Device Problem No Device Output (1435)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2018

Event Type  malfunction  

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 returned catheter was investigated.This investigation demonstrates that one wire is torn apart from the soldering pads on the pcb.Based on knowledge that the final inspection of the finished catheter was passed, that the catheter was delivered with proper functionality and in consideration of the results of performed investigation of returned catheter, the tear-off of the wire is caused by user error by stretching of the catheter during application contrary to ifu.[(b)(4)].

Event Description

After implantation of the catheter icp could be monitored for 1 hour.Afterwards icp measurement was no more possible.So the catheter was replaced by a new catheter.No additional anesthesia and no additional medicinal treatment was necessary.Health condition of the patient was not influenced by this.

• 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: reiner thiem ; hermann-staudinger-strasse 2; helmbrechts, 95233 ; GM 95233
• MDR Report Key: 8063755
• MDR Text Key: 128052387
• Report Number: 3006942548-2018-00005
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 092946-001
• Device Catalogue Number: 092946-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2018
• 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