MAUDE Adverse Event Report: SOPHYSA PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT; PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT

Model Number	PSO-PBT
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our experts performed a visual inspection and a functional controle.During the connection from the catheter to the monitor, the monitor displays a consistent pressure and temperature and the catheter seems to be reactive.Visual inspection of the functional part of the screw shows no abnormalities.The dimensional analysis confirms that the thread is within the theoretical specifications.After cleaning, a fixing test was carried out on a resin block, which shows that the bolt holds properly.Therefore, the catheter complies with our specifications and the bolt does not have dimensional anomalies that may explain the problem observed during use.As a result, the catheter is conform to its specification and the cause could not be confirmed.However, the use of this device must be taken with a special care when trepanning to ensure optimal bolt attachment.
Event or Problem Description
A part of the metal shaft of the icp device is visible (outside the bandage), and the assembly is slightly crooked.After checking, it appears that the bolt is very mobile, and no longer appears to be attached to the patient's skull, then the pressure curve on the monitor is lost.Explantation of the device.

• Brand Name: PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT
• Common Device Name: PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 10842272
• Report Number: 3001587388-2020-20581
• Device Sequence Number: 11695624
• Product Code: GWM
• UDI-Device Identifier: 03760124131758
• UDI-Public: (01)03760124131758(11)191115(17)241101
• 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 Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

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: 11/01/2024
• Device Model Number: PSO-PBT
• Device Catalogue Number: PSO-PBT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/16/2020
• 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: Other