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

Model Number	PSO-PBT
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Connected to a pressio monitor, the catheter displays 4 mmhg in the open air and is responsive to mechanical stress on the membrane.Tightening mark in bolt on the pa tube 5 mm from the capsule tested in a water column for approximately 3 days, normal behavior within 4mmhg.The catheter in return complies with our specifications (within zero offset), no drift or abnormal pressure values observed in use.
Event or Problem Description
On february 18, icp catheter has been implanted and is not functional.Negative number then 340.Changed 3 times.On february 19, icp catheter removed and replaced because the bolt does not fix the catheter.Implantation in the other side.On february 21, new implantation.

• Brand Name: PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
• Common Device Name: ICP AND ICT MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopôle temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: marion prudhomme ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 18911551
• Report Number: 3001587388-2022-22323
• Device Sequence Number: 12443288
• Product Code: GWM
• UDI-Device Identifier: 03760124131758
• UDI-Public: (01)03760124131758(11)210818(17)260801
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2026
• Device Model Number: PSO-PBT
• Device Catalogue Number: PSO-PBT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown