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

Model Number	ICP CATHETER
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to sophysa in-house process, the probe 15c00242 has been analyzed and tested by the quality control laboratory.The probe returned seems to be conformed to specifications.A fold appears on the tubing.Once connected to the monitor, it asks for zero procedure.Then, no error code was displayed.The first catheter display is compliant (-1mmhg).There is no error linked to the returned probe.Zero procedure has not been done by the user.
Event or Problem Description
After 36 hours of implantation, error code 999 appeared.

• 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: 6278359
• Report Number: 3001587388-2017-17034
• Device Sequence Number: 13741863
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• 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: 11/01/2020
• Device Model Number: ICP CATHETER
• Device Catalogue Number: PSO-PB
• Device Lot Number: C0051
• 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: 06/02/2016
• Initial Report FDA Received Date: 01/26/2017
• 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
• Patient Age: 10 YR