N
Patient 1
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.
MAUDE MDR 6873544
- MDR report key
- 6873544
- Report number
- 1125732-2017-00003
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-04-14
- Date received
- 2017-09-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. PETE PIFERI
- Address
- 5 MUSICK IRVINE CA 92618 US
- Phone
- 949-949-9499
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CLEARPOINT | NEUROLOGICAL STEREOTACTIC INSTRUMENT | MRI INTERVENTIONS, INC. | ORR | N/A | N/A | N/A | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-09-18 | 0 | 1. D |
Event Narratives#
D
Patient 1
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.