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U.S. Department of Health and Human Services

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

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RAUMEDIC AG NEUROVENT-P; NEUROLOGICAL CATHETER Back to Search Results
Model Number 092946-001
Device Problems No Device Output (1435); Missing Test Results (3267)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2017
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.
 
Event Description
After implantation of the catheter icp could be monitored for 6 hours.Afterwards the measurement could not continued also with useage of another mpr 1 datalogger.So the catheter has been explanted.No implantation of another catheter has been conducted.Failure of catheter did not result in an additional medication or operation.Health condition of the patient is well.
 
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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 Key7128254
MDR Text Key95792537
Report Number3006942548-2017-00003
Device Sequence Number1
Product Code GWM
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/22/2017
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 Date02/29/2020
Device Model Number092946-001
Device Catalogue Number092946-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/22/2017
Initial Date FDA Received12/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age5 YR
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