MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2016-06-08 for ONCOZENE MICROSPHERES UNK manufactured by Celonova Biosciences Germany Gmbh.
[46777938]
Additional investigation was performed to obtain the details of the event and the potential cause(s) that resulted in the rabbit's death. Based on available information, the individual conducting the procedure did not use enough contrast for the microsphere suspension and the procedure failed resulting in the tumor rupturing. Tumor rupture is a known complication with hypervascular tumors and is not device or treatment specific. This information is included in the adverse events section of the ifu.
Patient Sequence No: 1, Text Type: N, H10
[46777939]
Celonova received information that on (b)(4) 2016, during a study using rabbits on the hypervascular tumor model at the (b)(6), one of five animals treated experienced tumor rupture. In the communication received from the study laboratory, it was noted that on (b)(6) 2016, not enough contrast was added to the microsphere suspension and resulted in treatment failure and rupture of the target tumor. Embozene tandem microspheres were used in this study. Brand name is populated with oncozene microspheres, the similar product with 510(k) approval.
Patient Sequence No: 1, Text Type: D, B5
[49137495]
The root cause for not using enough contrast is insufficient training of the personnel performing the animal study: no training was performed in person due to travel interruption. The training was later completed over the phone, but no follow up occurred.
Patient Sequence No: 1, Text Type: N, H10
[49137496]
Celonova received information that on 05may2016, during a study using rabbits on the hypervascular tumor model at the (b)(6), one of five animals treated experienced tumor rupture. In the communication received from the study laboratory, it was noted that on (b)(6) 2016, not enough contrast was added to the microsphere suspension and resulted in treatment failure and rupture of the target tumor. Embozene tandem microspheres were used in this study. Brand name is populated with oncozene microspheres, the similar product with 510(k) approval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007240980-2016-00008 |
| MDR Report Key | 5705592 |
| Report Source | STUDY |
| Date Received | 2016-06-08 |
| Date of Report | 2016-06-08 |
| Date of Event | 2016-05-05 |
| Date Mfgr Received | 2016-05-09 |
| Date Added to Maude | 2016-06-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE FOSSAT-DOMINGUEZ |
| Manufacturer Street | 840 EL CAMINO REAL, STE.111 |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7636037008 |
| Manufacturer G1 | CELONOVA BIOSCIENCES GERMANY GMBH |
| Manufacturer Street | ERNST-ABBE-STRAUSSE, 40 D-8907 |
| Manufacturer City | ULM, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONCOZENE MICROSPHERES |
| Generic Name | EMBOLIC DEVICE |
| Product Code | NAJ |
| Date Received | 2016-06-08 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELONOVA BIOSCIENCES GERMANY GMBH |
| Manufacturer Address | ERNST-ABBE-STR. 40 D-89079 ULM, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-08 |