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

Model Number	095317-002
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2019
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-ifd-r (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 decision of the clinic to applicate a second icp catheter two days after initial application of the n-ifd-r is based on the fact that the n-ifd-r stopped working because of incorrect handling contrary to the ifu so all wires have been torn off.In accordance to the ifu the n-ifd-r has to be removed latest after 5 days.Eventually the implantation period exceeded up to 15 days, in which the leakage problem, again based on incorrect handling contrary to the ifu, occurred after 13 days of implantation, which we consider as off label use.(b)(4).
Event or Problem Description
The clinic placed an icp/drain (n-ifd-r) on (b)(6) 2019.Then on (b)(6) 2019 inaccurate icp values were reading in the 70's but only straight line no waveform.On (b)(6) 2019 an evd drain was connected to the n-ifd-r, so an icp monitoring was possible and also waveform and readings of 16-18 could be monitored, which is what patient had been reading previously.On (b)(6) 2019 the clinic decided to applicate another icp catheter to obtain accurate continuous icp readings.Left the n-ifd-r in to continue drainage.Then on (b)(6) 2019 the evd connection between n-ifd-r and evd drain came apart and started leaking csf.The clinic decided they need to attempt to repair the leakage as physician felt he would not be able to place another catheter based on the size of the ventricles.The clinic started patient on prophylactic antibiotics.On (b)(6) 2019 the clinic removed the system n-ifd-r / evd.Patient woke up moving extremities.

• Brand Name: NEUROVENT-IFD-R
• Common Device Name: NEUROLOGICAL CATHETER
• Manufacturer (Section D): RAUMEDIC AG; am mühlgraben 10; zwönitz, 08297 ; GM 08297
• MDR Report Key: 8738409
• Report Number: 3006942548-2019-00003
• Device Sequence Number: 14071846
• Product Code: GWM
• UDI-Device Identifier: 04057834029338
• UDI-Public: 04057834029338
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K120252
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2019

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: 09/30/2019
• Device Model Number: 095317-002
• Device Catalogue Number: 095317-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/27/2019
• 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