MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA EMBOSPHERE MICROSPHERES

Model Number	00884450403440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
The account alleges that a patient with hepatocellular carcinoma [hcc] without cirrhosis was admitted for planned transarterial chemoembolization (tace) of the right lobe & medial left lobe determined to be too advanced for surgical resection or transplant.The patient had a large liver-lung shunt preventing radioembolization treatment.The ir physician placed two vials of lc beads containing doxorubicin and administered bland transarterial embolization (tae) with embospheres [embolic] into the right hepatic artery.Post-procedure the patient demonstrated an acute drop in hemoglobin [hgb].Computed tomography angiography [cta] revealed multiple areas of active bleeding within the liver and the formation of a new hematoma.The ir physician performed a complete embolization of the right hepatic artery using coils and gelfoam to achieve hemostasis.The patient was then transferred to icu for observation and received blood products and continuous blood lab monitoring.The latter demonstrated hyperkalemia of 5.5 mmol/l, previously normal.Creatinine increased from 0.55mg/dl to 1.23, thought to be multifactorial.Additional workup revealed uric acid of 12.5mg/dl, calcium 6.9mg/dl & phosphorous 7.4mg/dl.Tls was diagnosed & treated with intravenous fluids for dilution, rasburicase for hyperuricemia, furosemide for renal dysfunction & minimal urine output, and insulin for hyperkalemia.Tumor lysis syndrome [tls] was assessed as related to the embosphere embolic treatment administration because the event developed after arterial embolization had been repeatedly performed for hepatocellular carcinoma [hcc].

• Brand Name: EMBOSPHERE MICROSPHERES
• Common Device Name: MICROSPHERES
• Manufacturer (Section D): BIOSPHERE MEDICAL SA; parc des nations, paris nord 2; 383, rue de la belle etoile; 95700 ; FR 95700
• MDR Report Key: 9767424
• Report Number: 9615728-2020-00003
• Device Sequence Number: 2704303
• Product Code: KRD
• UDI-Device Identifier: 00884450403440
• UDI-Public: 00884450403440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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 Model Number: 00884450403440
• Device Catalogue Number: S620GH/C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 50 YR