PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
Report
- Report Number
- 3001587388-2024-24368
- Event Type
- Death
- Date Received
- November 18, 2024
- Date of Event
- October 28, 2024
- Report Date
- March 14, 2025
- Manufacturer
- SOPHYSA
- Product Code
- GWM
- UDI-DI
- 03760124131758
- PMA / PMN Number
- K162108
- Adverse Event
- 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.
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. RÜTHER 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 KITS THAT ARE READY TO BE SEND TO CUSTOMER TO SEE IF THERE IS ANY BOLT BROKEN.
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.
IMPLANTATION ON (B)(6)2024 ON A HYPERTENSIVE PATIENT WITH RIGHT DEEP INTRACEREBRAL HEMATOMA. THE POSITION OF THE ICP CATHETER WAS CONFIRMED BY CT SCAN ON (B)(6)2024. AGGRAVATION OF INTRACRANIAL HYPERTENSION AT DAY 4 DIAGNOSED 1 DAY LATE, DUE TO CATHETER MIGRATION IN THE BOLT. THE CATHETER SLIPPED OUT OF THE BRAIN AND NO LONGER CORRECTLY MEASURED ICP (ICP AT 5MMHG BUT NOT PULSATILE). THE PATIENT EXPERIENCED ARTERIAL HYPOTENSION WITH AN AVERAGE OF 50 MMHG, BRADYCARDIA AT 35 BPM AND BILATERAL AREACTIVE MYDRIASIS. CATHETER REPLACEMENT ON (B)(6)2024 SHOWING ICP AT 30MMHG. DEATH OF THE PATIENT OCCURS ON (B)(6)2024.
IMPLANTATION ON (B)(6) 2024 ON A HYPERTENSIVE PATIENT WITH RIGHT DEEP INTRACEREBRAL HEMATOMA. THE POSITION OF THE ICP CATHETER WAS CONFIRMED BY CT SCAN ON (B)(6) 2024. AGGRAVATION OF INTRACRANIAL HYPERTENSION AT DAY 4 DIAGNOSED 1 DAY LATE, DUE TO CATHETER MIGRATION IN THE BOLT. THE CATHETER SLIPPED OUT OF THE BRAIN AND NO LONGER CORRECTLY MEASURED ICP (ICP AT 5MMHG BUT NOT PULSATILE). THE PATIENT EXPERIENCED ARTERIAL HYPOTENSION WITH AN AVERAGE OF 50 MMHG, BRADYCARDIA AT 35 BPM AND BILATERAL AREACTIVE MYDRIASIS. CATHETER REPLACEMENT ON (B)(6) 2024 SHOWING ICP AT 30MMHG. DEATH OF THE PATIENT OCCURS ON (B)(6) 2024.
IMPLANTATION ON (B)(6) 2024 ON A HYPERTENSIVE PATIENT WITH RIGHT DEEP INTRACEREBRAL HEMATOMA. THE POSITION OF THE ICP CATHETER WAS CONFIRMED BY CT SCAN ON (B)(6) 2024. AGGRAVATION OF INTRACRANIAL HYPERTENSION AT DAY 4 DIAGNOSED 1 DAY LATE, DUE TO CATHETER MIGRATION IN THE BOLT. THE CATHETER SLIPPED OUT OF THE BRAIN AND NO LONGER CORRECTLY MEASURED ICP (ICP AT 5MMHG BUT NOT PULSATILE). THE PATIENT EXPERIENCED ARTERIAL HYPOTENSION WITH AN AVERAGE OF 50 MMHG, BRADYCARDIA AT 35 BPM AND BILATERAL AREACTIVE MYDRIASIS. CATHETER REPLACEMENT ON (B)(6) 2024 SHOWING ICP AT 30MMHG. DEATH OF THE PATIENT OCCURS ON (B)(6) 2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2038195 | PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT | ICP AND ICT MONITORING CATHETER | GWM | SOPHYSA | PSO-PBT | 03760124131758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Death |