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

Model Number 100-300 UM

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Fever (1858)

Event Date 12/26/2014

Event Type  Injury  

Event Description

This report combines initial and f/u info, rec'd from the user facility via the co distributor on (b)(6) 2015 and (b)(6) 2015.This report concerns a (b)(6) pt with moderate biliary fistula.The pt's past medical history included hepatic cancer.Concomitant medications were reported as none.On (b)(6) 2014, the pt rec'd deb-tace procedure in hepatic artery a8 with a 10-fold dilution of dc bead (100-300um) 2 ml in total.The drug loading inco was not provided.On (b)(6) 2014, following the procedure, the pt developed severe abdominal pain and pyrexia (38 degrees c) and the pt rec'd a third generation cephem antibiotic.The pt was diagnosed with moderate biliary fistula which prolonged the pt's hospitalisation.On (b)(6) 2015, the pt was discharged from the hosp.The pt was placed with percutaneous drainage tube and transduodenal drainage tube and the pt rec'd outpatient f/u.On (b)(6) 2015, one of the tubes was removed and the pt currently visits the hosp once a week as an outpatient.At the time of this report, the pt did not completely recover from biliary fistula.The reporting physician stated that the biliary fistula was probably related to the dc bead.

Manufacturer Narrative

Dc bead was reported to have been used in the treatment of this pt.The equivalent prod 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 mfr for eval.No batch review was possible for this case as the lot number could not be ascertained.No prod malfunction/ deficiency has been identified.Co medical assessment: pt underwent deb-tace and later developed a biliary fistula.One of his tubes was removed indicating improvement.This is a serious adverse event and is medically reportable.The event is currently under investigation by the mfr and the conclusion of this investigation/ any new info rec'd will be communicated as a f/u report.

Manufacturer Narrative

(b)(4).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.Dc bead was reported to have been used with epirubicin which is considered an off-label use.The device has not been sent too the mfr 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 for follow up information indicates that the patient used previous rfa-this could have contributed to the events but this can't exclude user error involvement, so case remains medically reportable.Patient reported to be being treated with biliary drainage.This event is currently under investigation by the mfr and the conclusions of this investigation/any new information received will be communicated as a follow-up report.

Event Description

Previously reported information concerns a (b)(6) female patient with moderate biliary fistula.The patient's past medical history included hepatic cancer.The patient received deb-tace procedure with dc bead (100-300 um) 2ml in total.On the same day as the procedure, the patient developed severe abdominal pain and pyrexia (38 degrees c) and the patient received a third generation cephem antibiotic.The patient was diagnosed with moderate biliary fistula which prolonged the patient's hospitalization and the patient was later discharged from the hospital.The patient was placed with percutaneous drainage tube and transduodenal drainage tube and the patient received outpatient follow-up.The patient did not completely recover from biliary fistula.The reporting physician stated that the biliary fistula was probably related to dc bead.Additional information was received from a user facility via the company distributor on 03/11/2015, 03/18/2015 and 03/24/2015.The patient previously received radiofrequency ablation (rfa) (3 times excluding tace) and tace (9 times, non-dc bead).On (b)(6) 2014, the patient received dc bead loaded with 50mg of epirubicin.Following a abdominal ct scan a biliary fistula was suspected, later a definitive diagnosis was made with paracentesis.As of (b)(6) 2015, biliary fistula did not resolve.On (b)(6) 2015, subcutaneous biliary drainage and transduodenal biliary drainage were performed.The patient visited the hospital once a week on an outpatient basis and currently, the patient is being followed up with transduodenal biliary drainage alone.The reporting physician stated that the event was caused by fine bile ducts damage due to dc bead.

Manufacturer Narrative

Updated information received on this case indicates that the patient died from infection due to the biliary fistula that was thought to be related to the pace procedure.This is a medically reportable event.

Event Description

Additional information was received on august 11, 2015.Past medical history: hepatic cancer.At the time of tace procedure the pt had pyrexia and pain.On an unknown day in (b)(6) 2012, radiofrequency ablation (rfa) was performed.There was no perforation after pea.After the procedure, no severe abdominal pain or febrile symptom was observed.On (b)(6) 2014, tace was performed.The patient did not have previous dc bead tace therapy.After the procedure, no severe abdominal pain or febrile symptom occurred.On (b)(6) 2014, tace was performed in hepatic artery a8 with a 10-fold dilution of dc bead (100-300 um) 2 ml in total.At 72 hours after the procedure, the pt developed severe abdominal pain and pyrexia of 38 degrees c.A third generation cephen antibiotic was administered (immediately before tace, no treatment (therapy) possibly related to biliary fistula was performed).It was reported that the patient had no symptoms of abscess after tace treatment.On unknown date, an infection occurred after the development of internal biliary fistula.On (b)(6) 2015, the patient died due to the infection.The reporting physician stated that biliary fistula was probably related to dc bead and dc bead and death were possibly related.

• Brand Name: DC BEAD
• Type of Device: EMBOLIC AGENT, HCG/KRD
• Manufacturer (Section D): BIOCOMPATIBLES U.K. LIMITED; farnham business park; weydon ln; farnham, surrey GU9 8 QL; UK GU9 8 QL
• Manufacturer Contact: 252732732
• MDR Report Key: 4637867
• MDR Text Key: 5759323
• Report Number: 3002124545-2015-00011
• 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: Foreign,Health Professional,User Facility,Distributor,distributor,forei
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• 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
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 72 YR