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	05/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to sophysa in-house process, the probe 15c00441 has been analysed and tested by the quality control laboratory.Analyses performed show that the tubing presents a fold at 340 mm from the tip.Once connected to a pressio monitor the e001 error was confirmed.It is highly probable that the fold induced the breakage of one or several micro-wires inside the tubing leading to the e001 error.The icp pressio catheters are flexible, but cannot be bent in a such way without inducing an impairment.
Event or Problem Description
Problem with icp monitoring kit: the catheter showed e001 error.

• 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: 6272478
• Report Number: 3001587388-2016-16181
• Device Sequence Number: 16400597
• Product Code: GWM
• UDI-Device Identifier: 03760124130782
• UDI-Public: 3760124130782
• 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): 10/24/2016

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: 01/01/2015
• Device Model Number: ICP CATHETER
• Device Catalogue Number: PSO-PT
• Device Lot Number: C0076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2016
• 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