MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-09-05 for MRGFUS EXABLATE 2100 manufactured by Insightec Ltd.
[3818576]
Pt received a uterine fibroid treatment on (b)(6) 2013 by dr (b)(6) at (b)(6). Pt was diagnosed with skin redness and small blisters resemble skin burn of 1st or 2nd degree. Pt was released home with flammazine (burn treatment ointment). It was reported following blisters infection, pt was admitted in the special unit for skin burns at (b)(6) hospital. Pt underwent surgical resection of the burned tissue on the abdominal surface. Surgery went well without complications. Currently pt is recovering at home.
Patient Sequence No: 1, Text Type: D, B5
[11177463]
Device has been diagnosed to work according to it's specifications. Reason of adverse event may be defined as user error. Treating physician failed to notice skin heating. Insightec training material already explains and address such situations thus we did not find any room for improvement of procedure. Incident discussed with the site. Summary: there was no device malfunction or deterioration that would have caused this event. Our detailed analysis of this particular case shows that starting from sonication #15, we see several sonications showing temperature rise on the gel pad - skin interface, and some showing skin hyperemia on the magnitude fat saturated images. Otherwise, there were no unusual findings in pt positioning, treatment planning or treatment parameters. Because of the skin burn location, i. E. : gel pad-skin interface, we can only assume that the acoustic coupling between the pt and the gel pad around the location of the skin was problematic. Based on insightec past experience with these type of events, this could have been induced by microscopic air bubbles, or hydrophobic skin (i. E. Skin was not properly cleaned from potential oil based by-products). In any event, the treating physician did not notice the effects that were displayed on the mr images following sonication#15 and up. Action following this real time feedback could have helped minimize the event. Skin burn events are well known risks for the focused ultrasound procedure. However, the steps to eliminate them are also well known. In fact, since the implementation of all the mitigating steps in our insightec training, these events are indeed fairly rare. In response to this particular case, insightec application team will reach out to the treating physician to re-emphasize the role of the real time mr intra-procedure imaging, as well as full review of the steps to mitigate this type of events. It should be noted that this particular treating physician has treated more than 300 pts at a rate of 1 to 2 pts a day, and this is the first time they encountered such an event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615058-2013-00001 |
| MDR Report Key | 3335967 |
| Report Source | 01,07 |
| Date Received | 2013-09-05 |
| Date of Report | 2012-01-24 |
| Date of Event | 2012-12-12 |
| Date Mfgr Received | 2013-08-10 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2013-09-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ORI LUBIN, MGR |
| Manufacturer Street | 5 NAHUM HETH ST PO BOX 2039 |
| Manufacturer City | TIRAT CARMEL 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer Phone | 544881399 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MRGFUS EXABLATE |
| Generic Name | FOCUSSED ULTRASOUND |
| Product Code | NRZ |
| Date Received | 2013-09-05 |
| Model Number | 2100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC LTD |
| Manufacturer Address | 5 NAHUM HET TIRAT CARMEL 3912001 IS 3912001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-09-05 |