MAUDE Adverse Event Report: CELONOVA BIOSCIENCES GERMANY GMBH ONCOZENE MICROSPHERES; EMBOLIC DEVICE

Device Problem Use of Device Problem (1670)

Patient Problem Not Applicable (3189)

Event Date 05/05/2016

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ONCOZENE MICROSPHERES
• Type of Device: EMBOLIC DEVICE
• Manufacturer (Section D): CELONOVA BIOSCIENCES GERMANY GMBH; ernst-abbe-str. 40 d-89079; ulm, ; GM
• Manufacturer (Section G): CELONOVA BIOSCIENCES GERMANY GMBH; ernst-abbe-strausse, 40 d-8907; ulm, ; GM
• Manufacturer Contact: stephanie fossat-dominguez ; 840 el camino real, ste.111; carlsbad, CA 92008 ; 7636037008
• MDR Report Key: 5705592
• MDR Text Key: 46777938
• Report Number: 3007240980-2016-00008
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• PMA/PMN Number: K141209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1