MAUDE Adverse Event Report: SOPHYSA SA PARENCHYMAL PRESSIO CATHETER; ICP PRESSURE MONITORING CATHETER

Model Number	ICP CATHETER
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to sophysa in-house process, the probe (b)(4) has been analyzed and tested by the quality control laboratory.One connected to the pressio monitor, the error e001 was confirmed.It was observed that a one of the micro-wire inside the catheter was broken.This breakage is due to an abnormal and excessive elongation of the tubing of the probe.The icp pressio catheters are flexible but not stretchable, and therefore cannot be elongated in a such way without inducing impairment.Several hypothesis can explain this situation: during disconnection of the catheter from the extension cable, the user pulled on the catheter by handling the tubing.To avoid that problem its important to raise awareness of user to systematically hold the catheter using the connector during disconnection, to prevent this kind of damage.During nursing/move excessive traction has been applied to the catheter and/or the extension cable leading to micro-wire breakage.
Event or Problem Description
After passing the mri, no more values (error code e001).

• Brand Name: PARENCHYMAL PRESSIO CATHETER
• Common Device Name: ICP PRESSURE MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA SA; 5, rue guy moquet; orsay, cedex, 91400 ; FR 91400
• MDR Report Key: 6276104
• Report Number: 3001587388-2016-16213
• Device Sequence Number: 921586
• Product Code: GWM
• UDI-Device Identifier: 03760124130768
• UDI-Public: 3760124130768
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K062584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2016

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
• Operator of Device: No Information
• Device Expiration Date: 01/01/2021
• Device Model Number: ICP CATHETER
• Device Catalogue Number: PSO-PB
• Device Lot Number: D0041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2016
• Initial Report FDA Received Date: 01/25/2017
• 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