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 S220, 420, 620GH manufactured by Biosphere Medical, S.a..
[5831995]
Primary disease: right chest wall tumor (pathological diagnosis: possible solitary fibrous tumor). Vascular embolization was performed preoperatively for right chest wall tumor to reduce the amount of bleeding during surgery, as the tumor was huge and sanguineous. Before embolization, pentagin was administered for pain in the trunk. At this point, patient had a number of unidentified complaints and was awake and alert. Just when the procedure was almost finished, decreased blood pressure, tachycardia and increased electrocardiographic t wave amplitude developed. Decreased consciousness was noted at this point. Blood gas test, 12-lead electroradiography, ct of the trunk and mri of the head were performed. Ct of the trunk showed tumor growth and mri of the head showed multiple infractions bilaterally. Embosphere (probably the 100-300um) was considered likely to have spread systemically via an arterio-venous shunt or arterio-arterial shunt inside the tumor, leading to cerebral infarction.
Patient Sequence No: 1, Text Type: D, B5
[13411732]
Nothing is expected to be returned for evaluation. Since the lot number was not provided, the device history record and complaint database could not be reviewed for similar issues. (b)(4) medical/biosphere medical will continue to pay attention to the development of similar events. (b)(4) medical/biosphere medical will continue to pay attention to the development of similar events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615728-2015-00007 |
| MDR Report Key | 4808037 |
| Report Source | 01,07,08 |
| Date Received | 2015-05-29 |
| Date of Report | 2015-05-01 |
| Date of Event | 2015-01-19 |
| 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 | BAT.A.PARC DE NATIONS, PARIS NORD 2 383 RUE DE LA BELLE |
| Manufacturer City | ETOLLE ROSSY CH DE GAULLE CEDE |
| Manufacturer Country | FR |
| Manufacturer Phone | 4817252 |
| 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 | S220, 420, 620GH |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSPHERE MEDICAL, S.A. |
| Manufacturer Address | ROISSY-EN-FRANCE FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2015-05-29 |