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

Model Number	092946-002
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
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.The sales representative who was around during implantation procedure confirm initial functionality of the catheter.Furthermore returned catheter was investigated.This investigation demonstrates that one wire is torn off.Based on knowledge above 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.This is in according with the description of the customer, that the loss of icp occurred during the transport to the icu after successful implantation in the operating room.
Event or Problem Description
Shortly after successful implantation of the catheter icp could not be monitored anymore.The troubleshooting showed that no measurement were possible with a different nps2 or nps3.Massage "pressure sensor failure" appeared on the monitor when the zeroing process were done.A demo catheter worked fine connecting to the patient monitor.Therefore the doctor took the patient back to the operating room and replaced the catheter.The health condition of the patient was not influenced by this.Customer described that the loss of icp signal occurred during transport to icu after implantation.

• Brand Name: NEUROVENT-P
• Common Device Name: NEUROLOGICAL CATHETER
• Manufacturer (Section D): RAUMEDIC AG; am mühlgraben 10; zwönitz, 08297 ; GM 08297
• MDR Report Key: 8572732
• Report Number: 3006942548-2019-00002
• Device Sequence Number: 10828926
• Product Code: GWM
• UDI-Device Identifier: 04057834026108
• UDI-Public: 04057834026108
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K103206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2019

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: 01/31/2020
• Device Model Number: 092946-002
• Device Catalogue Number: 092946-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention