CLEARPOINT NEURO
Received Feb 2, 2022 · Event occurred Oct 16, 2018
Report 3002838670-2021-00001 · MDR key 13426115
Device
Generic name
Smartframe Xg
Manufacturer
Clearpoint Neuro, Inc.Catalog number
NGS-SF-02-11
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
BASED UPON AN INTERNAL REVIEW, IT WAS DETERMINED THAT THIS MDR WAS NOT LISTED IN THE MAUDE DATABASE. THE REASON FOR THIS IS UNKNOWN. THIS MDR IS THUS BEING FILED RETROACTIVELY AS PER THE INSTRUCTIONS OF THE EMDR HELP DESK.
Description of Event or Problem
DURING A CLEARPOINT PROCEDURE, THE DOCTOR INSERTED THE STYLET TO CONFIRM TARGET FOLLOWED BY INSERTION OF A VISUALASE LASER CATHETER. FOLLOWING ABLATION, THE ENTRY SITE WAS CLOSED. IT WAS LATER DETERMINED AFTER CLOSURE THAT THERE WAS A HEMORRHAGE THAT REQUIRED SURGICAL INTERVENTION. UPON FOLLOW UP, THE SURGEON COMMENTED THE PATIENT HAD FULLY RECOVERED WITH NO DEFICITS.