MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ONCOZENE; EMBOLIC DEVICE

Model Number	83905
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	12/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported necrosis occurred.Oncozene microspheres were selected to treat hepatocellular carcinoma (hcc) on (b)(6) 2020.There were no device performance issues.A follow-up ct scan on (b)(6) 2020 showed extensive necrosis and infarction to the right lobe.

• Brand Name: ONCOZENE
• Common Device Name: EMBOLIC DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11372880
• Report Number: 2134265-2021-02245
• Device Sequence Number: 3773786
• Product Code: KRD
• UDI-Device Identifier: 08714729942009
• UDI-Public: 08714729942009
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/26/2021
• Device Model Number: 83905
• Device Catalogue Number: 83905
• Device Lot Number: 0023650355
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/24/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR