MAUDE Adverse Event Report: BIOCOMPATIBLES U.K. LIMITED DC BEAD; EMBOLIC AGENT, HCD/KRD

Model Number 100 - 300 UM

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Fever (1858); Unspecified Infection (1930); Liver Damage/Dysfunction (1954); Test Result (2695)

Event Date 07/30/2014

Event Type  Injury  

Event Description

Initial and follow up information was received from a user facility, via a partner organization on september 19, 2014 and october 7, 2014 respectively.This report involves an (b)(6) male patient.The patient's hcc before tace was more than 3 tumor nodules with a maximum diameter of 25 mm.Hcc nodules were detected (10mm, 15mm and 25mm) with small nodules in segment 3 (s3).It was reported that the patient received 6 tace procedures totally and dc bead was used once.The patient received dc bead (100 - 300 um) via the tace procedure on (b)(6) 2014.Feeder arteries ran from a3 peripheral branches.A total of 1.6ml of dc bead (100-300 microm) was injected.The root of a3: 0.8ml; a3 branch: 0.6ml; and a3 branch: 0.2ml (1 vial/20ml of dilution of dc bead).On (b)(6) 2014, treatment with nexavar was initiated.On an unknown date in (b)(6) 2014, nexavar was discontinued since the patient developed acute pancreatitis.On (b)(6) 2014, pancreatitis improved.On (b)(6) 2014, the patient was discharged from the hospital.The patient continued to have a slight fever after leaving the hospital.On (b)(6) 2014, the patient's laboratory tests showed hepatic function disorder (liver function test high), hepatobiliary enzymes increased when the patient visited the hospital.Laboratory data showed alp 1137, gamma-gtp 334, crp 3.0, ast 76 and alt 83.On (b)(6) 2014, the patient revisited the hospital with severe abdominal pain and ct scan showed suspect biliary dilatation (computer tomography (ct) revealed a low-density area (approximately 4cm) in the liver s3 region), on the same day the patient was hospitalized and the laboratory data showed alp 1113, gamma-gtp 467, crp 4.18, ast 135 and alt 182.The patient was diagnosed with cholangitis, hepatic function disorder due to hepatic infarction or biliary ischaemia on the basis of ct scan.The reporting physician stated that hepatobiliary enzymes increased after infusion.On an unknown date in (b)(6), within a week, the patient improved with fasting and antibiotics during the hospitalization.It was reported that the patient would be discharged from the hospital.The reporting physician stated that the patient's cholangitis and hepatic function disorder were probable related.The report stated that the abdominal pain was not related.The physician also stated that the patient had history of right lobe hepatectomy for (b)(6) in 1990 and blood vessels in the remaining left lobe were thin and easily clogged.The reporting physician stated that the beads flowed back to a4 when the infusion was given to a3 peripheral branch during tace.It was not visualized from the root of a3 in angiography with even small amount of infusion.The physician stated that symptoms occurred after tace procedure.

Manufacturer Narrative

Dc bead was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.The device has not been sent to the manufacturer for evaluation.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.Company medical assessment: patient was diagnosed with acute pancreatitis, and then with cholangitis within several weeks of a deb-tace procedure.These events could possibly be due to inadvertent ectopic placement of embolization beads, possibly due to user error.The patient suffered significant harm.Accordingly, this event is medically reportable.

• Brand Name: DC BEAD
• Type of Device: EMBOLIC AGENT, HCD/KRD
• Manufacturer (Section D): BIOCOMPATIBLES U.K. LIMITED; farnham business park; weydon ln; farnham, surrey GU9 8QL; UK GU9 8QL
• Manufacturer Contact: farnham business park; weydon ln; farnham, surrey GU9 8-QL ; 252732732
• MDR Report Key: 4184251
• MDR Text Key: 5027247
• Report Number: 3002124545-2014-00027
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K094018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2014

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
• Device Operator: Health Professional
• Device Model Number: 100 - 300 UM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EPIRUBICIN HYDROCHLORIDE
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 80 YR
• Patient Weight: 49