MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-11-01 for EXABLATE 2000 * manufactured by Insightec, Ltd..
[520411]
A pt was treated for multiple hypo intense uterine fibroids using the company's exablate 2000 focused ultrasound device. Approximately 9 sonications were performed outside the fibroids on the intestine. During treatment, the patient did not report any specific complaints. Five days later, insghtec was informed that the patient underwent emergency surgery due to damage to her intestine. Thermal damage was seen and had to be excised. Upon investigation of the event, several errors were identified. Planning images clearly show intestine wedged between the rectus abdominis muscle and the uterus making it impossible to focus the beam on the fibroid without traversing the intestine. Some of the sonications were planned very close to the serosal surface and some even extended beyond it. Fiducials (used to identify patient or organ movements) were placed only on the superior edge of the bladder and on bony structures. None were placed on the uterus itself. The fiducials placed were not enough to identify lateral movements of the targeted fibroid. In order to enable treatment, in this particular case, the treating physician performed bladder filling. Since two fibroids were treated in this session, the treatment of this particular fibroid started about 2 hours and ended about 3. 5 hours after the planning. Images taken at the end of treatment clearly show a displacement of about 1. 7 cm of the uterus relative to its location at the planning stage. The result of this displacement was that some of the sonications which had been planned close to the serosa were now actually outside the uterus and in fact on the intestine. During treatment at least 9 sonications were performed outside the fibroid, as seen on the magnitude images where bowels are seen on the planning images.
Patient Sequence No: 1, Text Type: D, B5
[7801871]
During the company's investigation of this incident, it was determined that the device performed within its specifications and that user error was the root cause of the event. The treatment was replayed and company's experts could analyze every step of the treatment and data available at the site. The company's investigation determined that the event occurred because the physician failed to: identify that some of the sonications were outside of the fibroids; note that an intestine loop was wedged between the fibroid anterior aspect and rectus muscle; keep the 15mm safety margin between the spot margin and serosal lining; place the fiducials properly; and identify a shift in the fibroid on magnitude images relative to the planning images. The company will provide the agency with additional information if/when it becomes available. To address this event, insightec has performed the following remedial actions: review of the training procedure for application specialists; review of site training procedure; distribution of the case study (for this event) to all insightec application groups; and distribution of the case study (for this event) to all customers worldwide. The company will also perform device testing at the site to completely exclude malfunction option.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615058-2006-00003 |
| MDR Report Key | 777718 |
| Report Source | 05,07 |
| Date Received | 2006-11-01 |
| Date of Report | 2006-10-04 |
| Date of Event | 2006-09-29 |
| Date Mfgr Received | 2006-10-04 |
| Date Added to Maude | 2006-11-08 |
| 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 | ORI LUBIN, MANAGER |
| Manufacturer Street | 5 NACHUM HETH STREET P.O. BOX 2039 |
| Manufacturer City | TIRAT CARMEL 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer Phone | 9724813 16 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXABLATE 2000 |
| Generic Name | FOCUSED ULTRASOUND |
| Product Code | MIK |
| Date Received | 2006-11-01 |
| Model Number | EXABLATE 2000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 765496 |
| Manufacturer | INSIGHTEC, LTD. |
| Manufacturer Address | 5 NACHUM HETH STREET P.O. BOX 2059 TIRAT CARMEL IS 39120 |
| Baseline Brand Name | MK2 - EXABLATE |
| Baseline Generic Name | NA |
| Baseline Model No | EXABLATE 2000 |
| Baseline Catalog No | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2006-11-01 |