EDS3 CLEAR VENT CATH
Report
- Report Number
- 3013886523-2023-00357
- Event Type
- Injury
- Date Received
- October 19, 2023
- Date of Event
- September 28, 2023
- Report Date
- February 21, 2024
- Manufacturer
- INTEGRA LIFESCIENCES MANSFIELD
- Product Code
- JXG
- PMA / PMN Number
- K061568
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
THE EDS3 CLEAR VENTRICULAR CATHETER (ID 821735) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.
ON SEPTEMBER 28, 2023, A PHONE CALL WAS RECEIVED FROM A PATIENT CARE COORDINATOR WITH COMPLAINT OF EDS3 CLEAR VENTRICULAR CATHETER (ID 821735) HAVE CAUSED INTRACRANIAL HEMORRHAGES IN PATIENTS. MEDICAL STAFF ALSO NOTICED THAT THE STYLET HAS CHANGED FROM A FLEXIBLE CYLINDRICAL SHAPE TO A RIGID, THICK AND SQUARE SHAPE, AND BELIEVED THAT THE CHANGE IN STYLET HAS CAUSED INTRACRANIAL HEMORRHAGES IN PATIENTS. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED, AND IS ALSO UNKNOWN IF THE EVENT LED TO SURGICAL DELAY.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2054770 | EDS3 CLEAR VENT CATH | STANDARD EVD CATHETERS | JXG | INTEGRA LIFESCIENCES MANSFIELD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |