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

Model Number	PSO-PTT
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Pso-ptt icp monitoring device was implanted without complications.One day after implanting the device, the temperature measurement reportedly dropped from 37°c to 34°c which did not correlate well with the patient's health state.After explantation, when the catheter was tested, the temperature could only reach 34.9°c.No health complications or medical consequences were noted.
Event or Problem Description
One day after the catheter was implanted in the patient, the temperature measurement dropped from 37 degrees to 34 degrees.We tested the catheter, the temperature can only reach 34.9 degrees.
Additional Manufacturer Narrative
The catheter in return does not comply with our specifications, a short circuit (random contact) inside the tube between a wire of the temperature and pressure micro-cables can explain the defect in the temperature function.Case already encountered in the past on production scrap presenting the same symptoms.This is therefore a defect in the manufacturing process that is not detected and/or not easily detectable, a cut or alteration of the surface of one of the wires which, once inserted into the pa tube, comes into contact with one of the other nearby wires.And creates this random short circuit.Rare case of customer product returns.

• Brand Name: PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL TUNNELING
• 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; rue sophie germain; orsay, 91400 ; FR 91400
• MDR Report Key: 15841846
• Report Number: 3001587388-2022-22543
• Device Sequence Number: 5982356
• Product Code: GWM
• UDI-Device Identifier: 03760124131765
• UDI-Public: (01)03760124131765(11)211008(17)261001
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2026
• Device Model Number: PSO-PTT
• Device Catalogue Number: PSO-PTT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2021
• 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 Age: 36 YR
• Patient Sex: Male