MAUDE Adverse Event Report: SOPHYSA PRESSIO ICP MONITORING KIT, VENTRICULAR TUNNELING

Model Number	PSO-VT
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to sophysa in-house process, the returned catheter has been analyzed by sophysa quality control laboratory.Visual examination and functional control were performed.During the functional investigation, connected to a monitor it displays error message, sign of a connection fault.The visual inspection revealed a break in microcables on the electronic card, causing the observed fault.To conclude, taking into account the abnormal elongation of the catheter tube, the origin of this incident is an abnormal manipulation causing excessive elongation and having caused the rupture of the cables.
Event or Problem Description
The monitor displayed an error message e001 after implantation of the probe.

• Brand Name: PRESSIO ICP MONITORING KIT, VENTRICULAR TUNNELING
• Common Device Name: ICP MONITORING KIT
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 10475695
• Report Number: 3001587388-2020-20022
• Device Sequence Number: 2439572
• Product Code: GWM
• UDI-Device Identifier: 03760124131482
• UDI-Public: (01)03760124131482(11)191004(17)241001
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K162108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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 Model Number: PSO-VT
• Device Catalogue Number: PSO-VT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• 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