Table 8:
Adverse Events With MRgHIFU Treatment for Uterine Fibroids, From FDA MAUDE Database
| Event Date | Report Source, Reporter | Event | Outcome | Causation |
|---|---|---|---|---|
| Dec 12, 2012 | Manufacturer, physician | First- or second-degree abdominal skin burn | Hospitalization and uneventful surgical resection of burned abdominal tissue | Physician error |
| Nov 20, 2009 | Manufacturer, biomedical engineer | Failure of the console stop-sonication mechanism | Not an adverse event but the manufacturer sent an application note to all sites to test the stop-sonication button during power-up as a routine QA activity | Potential device malfunction |
| Sep 17, 2013 | Manufacturer, physician | Patient death | Cardiac arrest immediately following the procedure and successfully resuscitated. Her hemoglobin dropped from 10.8 gm/dl before treatment to approx. 3 gm/dl and improved following blood expanders, but a second cardiac arrest occurred and resuscitation was unsuccessful. | Uncertain; device technically intact and functioning within specifications and no device malfunctions; treatment appropriate. The institution did not have next-of-kin authorization to share medical records. |
| Sep 15, 2009 | Manufacturer, company representative | Potential issue detected in-house where certain modified ExAblate 2000 units could malfunction in that the system fails to correctly display the frequency spectrum during sonication | No adverse events occurred but instructions on maintaining safety margins of 10 mm from the serosa were repeated. | Potential device malfunction |
| Jan 1, 2009 | Voluntary, patient | Uterine carcinoma diagnosed within 1 year of HIFU | Patient had a hysterectomy and cancer was at an early stage. | Unrelated |
| Jul, 29, 2008 | Manufacturer, physician | 2 weeks after HIFU a bladder wall ulceration was diagnosed by a urologist | Patient was discharged after a 2-day hospitalization in which she received hemostatic interventions which stopped the bleeding. | Physician error |
| Jan 24, 2008 | Manufacturer, physician | Due to considerable undetected uterine motion during a large part of the treatment, sonication of structures outside the uterus resulted in nerve injury (14 and 15 nerve roots) in the right lumbosacral plexus and a bowel perforation: 2 in the ileum region and 1 in the sigmoid colon. | Hospitalized emergently for 9 days and, due to right foot weakness, was unable to walk without an aid; a rehabilitation assessment projected a 3-month recovery period. The patient underwent successful surgery for bowel perforations at another hospital. | Physician error |
| Jan 19, 2007 | Manufacturer, physician | Patient movement during sonication was undetected due to the inadequate use of fiducials (markers), leading to sonication of the bowel | Patient was hospitalized and underwent successful surgery for bowel repair. | Physician error |
Abbreviations: FDA, Food and Drug Administration; HIFU, high-intensity focused ultrasound; MAUDE, Manufacturer and User Facility Device Experience Database; MRgHIFU, magnetic resonance–guided high-intensity focused ultrasound; QA, quality assurance.