MAUDE Adverse Event Report: SOPHYSA SA VENTRICULAR 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	05/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned icp monitoring kit pso-vt has been received and analyzed by our quality control laboratory.Once connected to a pressio monitor, the e002 error was confirmed.This error means that there is a defect in the memory of the catheter.Some white deposit have been observed on the pins of the connector.These deposits are typical of liquid projections that induced electrical short circuit explaining the e002 error.In conclusion, the analysis carried out on the catheter showed that some liquid went into the dongle shell and created a short-circuit.This short-circuit is probably due to a misuse of the medical staff.As explained in the instructions for use, the catheter must be handle with care especially during zeroing process and nursing to avoid any liquid projection.
Event or Problem Description
Problem with the icp monitoring kit : the catheter showed e002 error.

• Brand Name: VENTRICULAR 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: 6263048
• Report Number: 3001587388-2016-16176
• Device Sequence Number: 13645561
• Product Code: GWM
• UDI-Device Identifier: 03760124131482
• UDI-Public: 3760124131482
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2016

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: Health Professional
• Device Expiration Date: 07/01/2019
• Device Model Number: ICP CATHETER
• Device Catalogue Number: PSO-VT
• Device Lot Number: B0439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2016
• Initial Report FDA Received Date: 01/19/2017
• 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