MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-09-18 for CLEARPOINT N/A manufactured by Mri Interventions, Inc..
[86551572]
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.
Patient Sequence No: 1, Text Type: N, H10
[86551573]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1125732-2017-00003 |
| MDR Report Key | 6873544 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-09-18 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-04-14 |
| Date Mfgr Received | 2017-04-11 |
| Date Added to Maude | 2017-09-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PETE PIFERI |
| Manufacturer Street | 5 MUSICK |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9499006833 |
| Manufacturer G1 | MRI INTERVENTIONS INC. |
| Manufacturer Street | 5 MUSICK |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEARPOINT |
| Generic Name | NEUROLOGICAL STEREOTACTIC INSTRUMENT |
| Product Code | ORR |
| Date Received | 2017-09-18 |
| Model Number | N/A |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MRI INTERVENTIONS, INC. |
| Manufacturer Address | 5 MUSICK IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-09-18 |