CLEARPOINT
Received Sep 18, 2017 · Event occurred Apr 14, 2017
Report 1125732-2017-00003 · MDR key 6873544
Device
Generic name
Neurological Stereotactic Instrument
Manufacturer
Mri Interventions, Inc.Model number
N/ACatalog number
N/A
Lot number
N/A
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
14 YR
- Death
- Death
Narrative
Additional Manufacturer Narrative
SURGEON BELIEVES THE EVENT WAS DUE TO THE CLEARPOINT/VISUALASE PROCEDURE INITIATING THESE CASCADING EVENTS, BUT ON REVIEW OF THE CASE COULD NOT DETERMINE A SPECIFIC CAUSE. DEVICE NOT RETURNED.
Description of Event or Problem
PTX HAD A PREVIOUS BIOPSY APPROXIMATELY 1 MONTH PRIOR TO THIS PROCEDURE CONFIRMING A GLIOMA. A CLEARPOINT/VISUALASE PROCEDURE WAS PERFORMED ON (B)(6). DURING THE PROCEDURE ALL INDICATIONS WERE NORMAL, WITH THE STYLET AND VISUALASE PROBE AT THE INTENDED TARGET. WITHIN 6-8 HOURS FOLLOWING COMPLETION THE PTX BEGAN TO DETERIORATE. EXAMINATION DETERMINED THE PTX HAD A SUBARACHNOID HEMORRHAGE. A DRAIN WAS PLACED TO RELIEVE PRESSURE. APPROXIMATELY 1-2 DAYS AFTER THE PTX EXPERIENCED A CEREBRUM STROKE AND SURGICAL DECOMPRESSION WAS PERFORMED, BUT THE PTX CONTINUED TO SUFFER PROGRESSING AND EVOLVING ISCHEMIA AND STROKE TO OTHER PARTS OF THE BRAIN. THE PATIENT DIED 4 DAYS AFTER THE PROCEDURE FROM PROGRESSING AND EVOLVING ISCHEMIA AND STROKE.