PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
Report
- Report Number
- 3001587388-2024-24378
- Event Type
- Malfunction
- Date Received
- November 18, 2024
- Date of Event
- November 18, 2024
- Report Date
- March 14, 2025
- Manufacturer
- SOPHYSA
- Product Code
- GWM
- PMA / PMN Number
- K162108
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
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.
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. FUTHER 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 PRESSIO(R) KITS THAT ARE READY TO BE SEND TO CUSTOMER TO SEE IF THERE IS ANY BOLT BROKEN.
THE CATHETER IS NOT FIXED IN THE BOLT WHEN IT IS IN HOLDING POSITION.
THE CATHETER IS NOT FIXED IN THE BOLT WHEN IT IS IN HOLDING POSITION.
THE CATHETER IS NOT FIXED IN THE BOLT WHEN IT IS IN HOLDING POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2604364 | PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT | ICP AND ICT MONITORING CATHETER | GWM | SOPHYSA | PSO-PBT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |