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	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No corrective or preventive action has been taken since we don't know at which moment the problem occurs.But a sensibilization of all the operator has been made.Further analysis must be performed to determine when the bolt has been broken (at the manufacturing site or at the hospital).The manufacturer will contact the reporter to investigate on this part.On the same time, the quality team will control bolt of pression kits that are ready to be send to customer to see if there is any bolt broken.
Event or Problem Description
The catheter is not fixed in the bolt when it is in holding position.
Additional Manufacturer Narrative
A capa2024-05 has been opened in order to put in place corrective action to prevent the apparition of this misuse.The action plan is not yet finished.No further investigation will be made since the root cause has been found to be related to misuse of the device : tightening the bold when the stylet is still inside that provoke the breakage of the locking clip and prevent the bolt from keeping the catheter in place for a correct monitoring of the patient.
Event or Problem Description
The catheter is not fixed in the bolt when it is in holding position.
Event or Problem Description
The catheter is not fixed in the bolt when it is in holding position.
Additional Manufacturer Narrative
Follow-up1: a capa2024-05 has been opened in order to put in place corrective action to prevent the apparition of this misuse.The action plan is not yet finished.No further investigation will be made since the root cause has been found to be related to misuse of the device : tightening the bold when the stylet is still inside that provoke the breakage of the locking clip and prevent the bolt from keeping the catheter in place for a correct monitoring of the patient.Follow-up2: all the investigations confirmed that the defect was identical on both returned devices and corresponded to deformation and damage to the clamp in the bolt.Based on our investigation results and on physicians' feedback we can demonstrate that complaints are due to users, from one specific center, who did not properly follow instructions for use.In conclusion the root cause is : user error.According to the fda's requested labeling change for pressio 2 icp monitoring system, k162108, the ifu will be updated to add a statement in catheter implantation section.

• 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 môquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopole temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy môquet; orsay, 91400 ; FR 91400
• MDR Report Key: 20704053
• Report Number: 3001587388-2024-24377
• Device Sequence Number: 9904302
• Product Code: GWM
• UDI-Device Identifier: 03760124131758
• UDI-Public: (01)03760124131758(11)240411(17)290201
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2025

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-PBT
• Device Catalogue Number: PSO-PBT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 10/31/2024; 10/31/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/20/2024; 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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: 50 YR
• Patient Sex: Male