MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-29 for EXABLATE 4000 SYS004000-AA manufactured by Insightec, Ltd..
[83964943]
*note: exablate 4000 is not indicated for use in the treatment of hypothalamic harmartoma (hh) under p150038. **note: evalution summary: relevant clinical background (patient age, gender, indication for treatment, description of treatment target, general status, other relevant clinical findings) female, (b)(6), treated for hypothalamic hamartoma (hh) epilepsy. She was operated twice in the past. Patient had a cyst dorsal to the target. Patient had previous craniotomy. Relevant treatment flow description treatment consisted of 12 sonications, target was the junction between the hypothalamus and the hamartoma. Maximal temperature that was reached at sonication no. 10 was 54? C at 4 mm away from the visual tract. All other sonications did not pass the t=51? C. Treatment analysis (adequate and inadequate treatment decisions and acts) as part of insightec standard of operation, the full treatment was reviewed in details including and not limited to this specific ae. As seen on the thermal images, the hot spot was smeared (elongated) in the anterior posterior direction and extended laterally. Areas beyond 50? C were always confined to the target and >5mm away from the visual tract; none of the sonications resulted in more than 52? C. As the spot was smeared, treatment was stopped after 12 sonications to avoid temperatures >48? C outside the target. In the 1 day post treatment t2w mr images there seems to be some hyperintensity in the treated area. This was the 1st hh treatment in (b)(6). The event may have been a result of the proximity of the target to the visual tract and specifically to edema resulted after the treatment.
Patient Sequence No: 1, Text Type: N, H10
[83964944]
A (b)(6) female was treated with the exablate neuro system at the (b)(6) for hypothalamic hamartoma (hh) epilepsy. Two days post-treatment, the patient experienced a visual field cut in the lower half of the left eye with no decline in visual acuity. It was reported that event may be related to the pressure on the visual crossover and expansion of edema and swelling of the lesion itself observed on the mr images taken 1 day post treatment. Patient was treated with steroids and followed up with mr images before and after about 7 days. The solidified layer was well formed, and three clotting foci were created in the dwi image. Two weeks post treatment site reported that the patient has still visual field cut problem. They plan visual field examination in (b)(6) by ophthalmologist and an outpatient clinic visit in (b)(6) at (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2017-00002 |
| MDR Report Key | 6829279 |
| Date Received | 2017-08-29 |
| Date of Report | 2017-08-29 |
| Date of Event | 2017-06-20 |
| Date Facility Aware | 2017-06-25 |
| Report Date | 2017-06-25 |
| Date Reported to Mfgr | 2017-06-25 |
| Date Mfgr Received | 2017-06-25 |
| Date Added to Maude | 2017-08-29 |
| 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. IDAN COHEN |
| Manufacturer Street | 5 NACHUM HETH STREET P.O. BOX 2039 |
| Manufacturer City | TIRAT CARMEL, ISRAEL 39120 |
| Manufacturer Country | IS |
| Manufacturer Postal | 39120 |
| Manufacturer G1 | INSIGHTEC, LTD |
| Manufacturer Street | 5 NACHUM HETH STREET P.O. BOX 2039 |
| Manufacturer City | TIRAT CARMEL, ISRAEL 39120 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 39120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EXABLATE 4000 |
| Generic Name | MR-GUIDED FOCUSED ULTRASOUND SYSTEM |
| Product Code | POH |
| Date Received | 2017-08-29 |
| Model Number | EXABLATE 4000 |
| Catalog Number | SYS004000-AA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC, LTD. |
| Manufacturer Address | 5 NACHUM HETH STREET P.O. BOX 2039 TIRAT CARMEL, ISRAEL 31290 IS 31290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-29 |