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

Model Number	ICP CATHETER
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal documentation shows that the catheter has been manufactured in accordance with the quality requirements and does not show any performance abnormality or any causality relationship between the reported incident and the suspected device.According to sophysa in-house process, the returned catheter has been analysed by our quality control laboratory and a visual and functional control were performed.Functional control confirmed the error e001.Visual inspection revealed that the microcable is brocken near the dongle shell, due an excessive and abnormal traction during use.To conclude, the rupture of the microcable and so the e001 is due to a misuse of the device, or to an excessive traction by the restless patient.
Event or Problem Description
The probe has implanted on (b)(6) 2020 at night.On (b)(6) 2020, the monitor showed e001.During the night, the patient was restless, he could have pulled on the catheter.

• Brand Name: PARENCHYMAL PRESSIO CATHETER
• Common Device Name: ICP MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA; 5, rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 10476824
• Report Number: 3001587288-2020-20207
• Device Sequence Number: 2553121
• Product Code: GWM
• UDI-Device Identifier: 03760124130768
• UDI-Public: (01)03760124130768(11)191220(17)241201
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K162108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2020

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: 12/01/2024
• Device Model Number: ICP CATHETER
• Device Catalogue Number: PSO-PB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 09/01/2020
• 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