MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2015-05-29 for EMBOSPHERE MICROSPHERES 500-700 S620GH manufactured by Biosphere Medical, S.a..
[5892221]
Primary disease: haemangioma of liver. On (b)(6) 2014, initial hepatic embolization was performed preoperatively for a large haemangioma of the liver. On (b)(6) 2015, the haemangioma was not sufficiently shrunk, and a 2nd arterial embolization as thus performed. This time, the right hepatic artery (rha) and a4 branch (the medial branch of the left hepatic artery) were embolized with embosphere 500-700 um (using 3. 8ml out of 20ml of the solvent prepared). As embolization was performed at the origin of rha, inflow of the spheres was also noted in the cystic artery, disrupting the blood flow at the fundus of the gallbladder. After embolization, abdominal pain persisted. On (b)(6) 2015, computer tomography was performed, showing necrosis of the fundus of the gallbladder. On the same day, cholecystectomy and resection of the haemangioma were performed concurrently due to a risk of rupture. On (b)(6) 2015, the patient recovered from gallbladder necrosis and was discharged.
Patient Sequence No: 1, Text Type: D, B5
[13416790]
Results: device problems that occur during the performance, use or functioning of the device. Conclusions: device problems known and documented in the labeling (including both short or long term known complications or adverse reactions). (b)(4)/biosphere medical will continue to pay attention to the development of similar events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615728-2015-00008 |
| MDR Report Key | 4808042 |
| Report Source | 01,07,08 |
| Date Received | 2015-05-29 |
| Date of Report | 2015-05-01 |
| Date of Event | 2015-01-30 |
| Date Mfgr Received | 2015-05-01 |
| Date Added to Maude | 2015-06-02 |
| 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 | ALIX FONLLADOSA |
| Manufacturer Street | PARC DE NATIONS, PARIS NORD 2 383 RUE DE LA BELLE |
| Manufacturer City | ETOLLE ROSSY CH DE GAULLE CEDE |
| Manufacturer Country | FR |
| Manufacturer Phone | 48172525 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOSPHERE MICROSPHERES |
| Product Code | NAJ |
| Date Received | 2015-05-29 |
| Model Number | 500-700 |
| Catalog Number | S620GH |
| Lot Number | X447276 |
| Device Expiration Date | 2015-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSPHERE MEDICAL, S.A. |
| Manufacturer Address | ROSSY-EN-FRANCE FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-05-29 |