MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-10-02 for EXABLATE 2100 manufactured by Insightec, Ltd..
[3797401]
The pt was a (b)(6) female being treated for diffused uterine adenomyosis. Per the exablate adenomyosis treatment protocol, all sonications were normal: mode 0 with 16 seconds of duration, energy level of approx 2,100 joules per sonication for all sonications. The post treatment images (t2 and t1 contrast) which, were done about 10-15 mins after completion of therapeutic sonications, did not show bleeding or fluid in the uterus or the abdominal cavity or in the retroperitoneum. About 30-35 mins after the immediate post treatment, imaging was completed, which in itself takes 10 to 15 mins, and while the pt was changing into her clothes, the pt collapsed and had cardiac arrest. Following energy procedure(s) for such cases, the pt was successfully resuscitated. Her hb was found to have dropped from approx 10. 8 gm/dl pretreatment, to approx 3 gm/dl. She received blood expanders and improved, but soon afterwards she had a second cardiac arrest; this time resuscitation was unsuccessful. Reporter shared with the company's medical director that the autopsy report indicated that the pt uterus was intact, with blood around the uterus that originated from a "blood vessel in the lower abdomen, not in the treated area. " no further info is available as the institution does not have the next of kin authorization to share medical records.
Patient Sequence No: 1, Text Type: D, B5
[11203143]
Post-event medical review indicated the following: enlarged uterus with diffuse adenomyosis; the non-perfused volume (npv) seen in the post treatment images was confined within the uterus, only; at least 1. 5 cm from the posterior uterine serosa; no significant fluid or bleeding signs could be detected in the abdominal cavity or retro-peritoneum; and blood vessels around the uterus looked intact. The full review of the treatment showed that the device was functioning according to insightec specification, and there was no device malfunction. Dr (b)(6) treatment analysis indicates that the treatment basically followed insightec treatment guidelines, using relatively low levels of energy, and confirmed to the uterus. This was further corroborated by the finding of the immediate post-treatment mri imaging showing the treatment effect well confined into the uterus. There were no reported product deficiencies. An on-site technical test of the sys was performed by insightec rep post the event (using daily quality assurance, dqa, test procedure) demonstrating that the sys is technically intact and functioning within spec. Per an eval by individuals with the appropriate medical expertise, there was not a reasonable possibility that the device caused or contributed to the event. Due to the ltd info provided by the initial reporter, although a conclusive cause for the reported pt effects and the relationship to the device, if any, cannot be determined, nor can the potential for causation be eliminated, there is no indication of a product quality deficiency with respect to manufacture, design, or labeling. Out of an abundance of caution, the event is being reported to fda. The info submitted reflects all relevant data received. If addition relevant info is received, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615058-2013-00003 |
| MDR Report Key | 3397232 |
| Report Source | 05 |
| Date Received | 2013-10-02 |
| Date of Report | 2013-10-11 |
| Date of Event | 2013-09-17 |
| Date Mfgr Received | 2013-09-23 |
| Device Manufacturer Date | 2009-12-03 |
| Date Added to Maude | 2013-10-10 |
| 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 | NADIR ALIKACEM |
| Manufacturer Street | 4851 LBJ FREEWAY STE. 400 |
| Manufacturer City | DALLAS TX 75244 |
| Manufacturer Country | US |
| Manufacturer Postal | 75244 |
| Manufacturer Phone | 2146302000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXABLATE 2100 |
| Product Code | NRZ |
| Date Received | 2013-10-02 |
| 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 ST. TIRAT CARMEL 39120 IS 39120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2013-10-02 |