MAUDE Adverse Event Report: SOPHYSA PRESSIO® ICP MONITORING KIT, PARENCHYMAL TUNNELING; ICP MONITORING CATHETERS

Model Number	PSO-PT
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Implantation of the device the 6th of february.The machine showed the incorrect pressure after the patient did a ct scan at february 10.The chief physician put the catheter into the normal saline, the machine showed 58mmhg.We did the test and the machine showed 55mmhg.Explantation of the device the same day.
Additional Manufacturer Narrative
Analysis: breaking the capsule/tube connection leaves the inside of the capsule/sensor in the open air, distorting the pressure measurement.Pressure build-up is no longer correct, and the sensor becomes unstable, drifting to an abnormally high and erroneous pressure value.Conclusions : the return catheter does not comply with our specifications.An abnormally high pressure is displayed due to a broken capsule/pa tube connection.Note: the kt worked for about 4 days, no access to the kt memory history.
Event or Problem Description
Implantation of the device the (b)(6).The machine showed the incorrect pressure after the patient did a ct scan at february 10.The chief physician put the catheter into the normal saline, the machine showed 58mmhg.We did the test and the machine showed 55mmhg.Explantation of the device the same day.

• Brand Name: PRESSIO® ICP MONITORING KIT, PARENCHYMAL TUNNELING
• Common Device Name: ICP MONITORING CATHETERS
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer Contact: marion prud'homme ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 17016916
• Report Number: 3001587388-2023-23147
• Device Sequence Number: 6163832
• Product Code: GWM
• UDI-Device Identifier: 03760124130782
• UDI-Public: (01)03760124130782(11)220801(17)270601
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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-PT
• Device Catalogue Number: PSO-PT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 05/29/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (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 Age: 56 YR
• Patient Sex: Female