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
According to sophysa in-house process, the probe 14c02788 has been analysed and tested by the quality control laboratory.Analyses performed show that the probe tubing present no defect.Once connected to a pressio monitor the e001 error was confirmed.Consequently the connector of the catheter has been opened and it has been observed that one of the micro-wire inside was broken.This breakage is probably due to an excessive traction on the tubing of the probe.Several hypothesis can explain this situation: during disconnection 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.To avoid that situation the manufacturer advices: to fix the catheter extension cable to the bed sheets thank to the dedicated clamps.To make one loop with catheter tubing and to attach the loop thus formed thank to the fixation tab to patient's scalp.
Event or Problem Description
Problem with icp monitoring kit : the catheter showed e001 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: 6272447
• Report Number: 3001587388-2016-16180
• Device Sequence Number: 19097050
• 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
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2016

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: 06/01/2019
• Device Model Number: ICP CATHETER
• Device Catalogue Number: PSO-VT
• Device Lot Number: B0339
• 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: 01/24/2017
• 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