MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2008-02-19 for EXABLATE 2000 manufactured by Insightec-txsonics, Ltd..
[16840000]
Neuropraxia with l5 involvement. Loss of sensation in l5 initially detected. She also had severe abdominal pain the following day due to gaseous distension of the bowel, which resolved after one day of treatment. X-ray of abdomen showed mild bowel distension. Fever of 38 deg c was noted, but resolved. Has weakness with dorsiflexion of the right ankle joint. Location of the ae by body system: right lumbosacral plexus (assessment by neurologist: l4, l5 plexopahty) she was treated for paraesthesia (painful sensation on top of foot) by hospital pain management team. Pt developed acute abdominal pain again, and the x-ray done the following day showed bowel perforations in the ileum and sigmoid colon. Neurologist assessment emg 4 days post treatment (2008) showed l4, l5 lumbar plexopathy. Need to repeat study in 3 weeks' time for conclusive results. Presently still in hospital (9 days) able to walk with aid. Undergoing physiotherapy. The pt (initials c. H. A) was treated on four days earlier. The treatment has been described to go well although the pt pushed the stop sonication button and stopped several sonications, presumably due to excessive pain. In addition, according to the testimony of the treating physician, at the beginning of the treatment, after several sonications, the physician detected that motion had taken place. According to instructions, treatment was stopped and replanned based on the new images. After that the treatment continued to conclusion without any add'l corrections. Post treatment the pt complained of rear thigh pain and weakness. The weakness was initially thought to be related to the pain only. However, it later extended to weakness of her right foot and she was unable to walk without assistance. Neurological assessment (emg) suggests axonal injury to l4 and l5 nerve roots. On the following month, the pt developed what was diagnosed as bowel perforation and underwent surgery at another hospital. Final conclusions from surgery were that she had 3 perforations, 2 were in the ileum region and the 3rd was in sigmoid colon. The pt recovered well from surgery and is being released from hospital today, 12 february. Regarding the leg problem, the pt is walking with aid, a frame. The power in her leg is coming back slowly although she is still in some pain. The rehabilitation people believe it should take her around 3 months to recover from the nerve injury.
Patient Sequence No: 1, Text Type: D, B5
[16900649]
Analysis and conclusions: a technical analysis based on the treatment images and data is attached as appendix 1. From this analysis it is clear that the main problem was the considerable motion of the uterus that was not noticed by the treating physician. Both the written training material as well as the curriculum of the training sessions put special emphasis on checking for motion after every sonication, since motion that is not corrected for causes energy to be deposited not at the planned locations. The result of that can be damage to structures outside the fibroid volume such as nerves and intestines, as indeed most probably happened in the current case. In fact the physician in this particular case had add'l warning that should have caused add'l checking for motion both because many of the planned spots were yellow, a warning that tells the physician to take special care and because the pt stopped several sonications, which usually indicates excessive pain. Also, it is clear that she was well aware of the instructions, since at the beginning of the treatment she did stop once and re-plan after detecting motion. In view of the above it can be concluded that the adverse event was caused by sonicating structures outside the fibroid due to the physician's omission of checking for pt motion during a large part of the treatment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615058-2008-00002 |
| MDR Report Key | 1001500 |
| Report Source | 01,07 |
| Date Received | 2008-02-19 |
| Date of Report | 2008-02-17 |
| Date of Event | 2008-01-24 |
| Date Mfgr Received | 2006-04-30 |
| Date Added to Maude | 2008-04-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ORI LUBIN, MGR |
| Manufacturer Street | 5 NAHUM ST. PO BOX 2039 |
| Manufacturer City | TIRAT CARMEL 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer Phone | 9724813162 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXABLATE 2000 |
| Generic Name | MRGFUS |
| Product Code | NRZ |
| Date Received | 2008-02-19 |
| Model Number | EXABLATE 2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 991513 |
| Manufacturer | INSIGHTEC-TXSONICS, LTD. |
| Manufacturer Address | 5 NACHUM ST. PO BOX 2059 TIRAT CARMEL IS 39120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-02-19 |