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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our experts performed a visual inspection and a functional control of the returned device.Visual inspection showed some dry blood deposits and a clear cut in the tube at 90 mm from the capsule making the micro-cable visible.The functional control showed that the pressure and temperature values were conform at the first connection to the monitor.By keeping the kt connected to the monitor, manual stressing of the tube close to the cut area allows the e001 fault found in use to be reproduced.As a result, the default is confirmed, the catheter is not conform to its specifications.A cut of the tube during the use caused a cut in the micro-cable resulting in the error message e001.
Event or Problem Description
24h after implantation, the catheter showed an error message e001.

• 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: 11100327
• Report Number: 3001587388-2020-20683
• Device Sequence Number: 3786153
• Product Code: GWM
• UDI-Device Identifier: 03760124131765
• UDI-Public: (01)03760124131765(11)200313(17)250301
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K162108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/31/2020

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: 03/01/2025
• Device Model Number: PSO-PBT
• Device Catalogue Number: PSO-PBT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/31/2020
• 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