MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2006-02-21 for EXABLATE 2000 * manufactured by Insightec, Ltd..
[403388]
Based on the information provided to insightec by the facility in 2006, it appears that a pt who had undergone a 2. 5 hour exablate 200 treatment for uterine fibroids in 2005 was diagnosed with a non-occlusive thrombus in her right leg the day after receiving the mr guided focused ultrasound ("mrgfus") treatment. This event was determined by the treating doctor to be "possibly related" to the device, although no explanation as to how the event could be related to the treatment is provided. According to the clinic, the pt was hospitalized for several days, received treatment (i. E. , administration of anticoagulant) and later underwent a percutaneous thrombectomy at a different facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616058-2005-00002 |
| MDR Report Key | 678624 |
| Report Source | 01,07 |
| Date Received | 2006-02-21 |
| Date of Report | 2006-02-20 |
| Date of Event | 2006-01-26 |
| Device Manufacturer Date | 2005-02-01 |
| Date Added to Maude | 2006-02-27 |
| 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 | DOV MAOR, VICE PRESIDENT |
| Manufacturer Street | 5 NACHUM HETH STREET P.O. BOX 2039 |
| Manufacturer City | TIRAT CARMEL 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer Phone | 9724813131 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | PM |
| 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 | 2006-02-21 |
| 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 | 667891 |
| Manufacturer | INSIGHTEC, LTD. |
| Manufacturer Address | 5 NACHUM HETH STREET P.O. BOX 2059 TIRAT CARMEL IS 39120 |
| Baseline Brand Name | EXABLATE 2000 |
| Baseline Generic Name | FOCUSED ULTRASOUND |
| Baseline Model No | EXABLATE 2000 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2006-02-21 |