MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD DC BEAD; HCG/KRD

Model Number 100-300 UM

Device Problem Insufficient Information (3190)

Patient Problems Encephalopathy (1833); Ascites (2596)

Event Date 11/14/2014

Event Type  Injury  

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.

Event Description

Massive ascites [ascites] encephalopathy [encephalopathy] case description: initial information received on 28-dec-2015: this literature medical device report entitled "evaluation of te4 predictive factors of in deb-tace" by shitase shigeo et al.(division of gastroenterology, department of medicine, kurume university) was received from a physician via the company distributor, and concerned a (b)(6) male.No medical history and no concomitant medication were reported on an unspecified date, tace was performed for hepatocellular carcinoma (hcc) with dc bead (100-300 microm).On (b)(6) 2014, computerised tomogram (ct) scan was conducted twice and revealed massive ascites and encephalopathy.On (b)(6) 2014, ascites and encephalopathy were recovering and the patient was discharged.The physician did not assess the seriousness of the events and considered both events (ascites and encephalopathy) as probably related to dc bead treatment the company assessed both events as serious (hospitalization).Case comment: ascites and encephalopathy are considered unlisted according to dc bead current instruction for use.The physician considered the events of ascites and encephalopathy as probably related to the use of dc bead.Although the underlying liver disease of the patient could have contributed to the event, the company also considered the events to be related to the tace procedure since this possibility cannot be excluded.This single case report does not modify the risk benefit balance of dc bead.The company is continuously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.The first sales for dc bead in the (b)(6) were in 2004.Sales data from (b)(6) 2010 for dc bead is: (b)(6).

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.

Event Description

Massive ascites [ascites] , encephalopathy [encephalopathy], off-label use [off label use of device].Case description: initial information received on (b)(6) 2015: this literature medical device report entitled "evaluation of te4 predictive factors of in deb-tace" by shitase shigeo et al.(division of gastroenterology, department of medicine, kurume university) was received from a physician via the company distributor, and concerned a (b)(6).No medical history and no concomitant medication were reported.On an unspecified date, tace was performed for hepatocellular carcinoma (hcc) with dc bead (100-300 microm).Mfr report # uf/importer report #.On (b)(6) 2014, computerised tomogram (ct) scan was conducted twice and revealed massive ascites and encephalopathy.On (b)(6) 2014, ascites and encephalopathy were recovering and the patient was discharged.The physician did not assess the seriousness of the events and considered both events (ascites and encephalopathy) as probably related to dc bead treatment the company assessed both events as serious (hospitalization).Additional information received on 10-feb-2016: risk assessment: the information in this case comes from a published report in the literature.Further follow-up is being sought by btg.In this case, a patient received treatment with dc beads for hepatocellular carcinoma.At an unspecified time after the procedure, the patient presented with ascites and hepatic encephalopathy.Because of the unknown interval, it is difficult to assess whether the development of these symptoms may have been related to the dc bead treatment (in which case it would have occurred due to ectopic placement of beads in normal liver tissue in addition to/or instead of the target tumor).The event could also have occurred due to natural progression of the underlying liver disease and tumor if sufficient time had passed.However, even if the event was due to ectopic bead placement, this is a known risk of the procedure currently listed in the product ifu.Accordingly, this single event does not represent a change in the low risk of this complication, and may, in fact, be related to underlying disease progression rather than dc bead treatment.Fsca: this report would not constitute the need for a field safety corrective action.These are known and documented risks of the procedure and do not constitute a change to the established benefit risk profile of the product.(b)(4).Case comment: ascites and encephalopathy are considered unlisted according to dc bead current instruction for use.The physician considered the events of ascites and encephalopathy as probably related to the use of dc bead.Although the underlying liver disease of the patient could have contributed to the event, the company also considered the events to be related to the tace procedure since this possibility cannot be excluded.This single case report does not modify the risk benefit balance of dc bead.The company is continuously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.

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.

Event Description

Massive ascites [ascites].Encephalopathy [encephalopathy].Off-label use [off label use of device].Case description: initial information received on (b)(6) 2015: this literature medical device report entitled "evaluation of te4 predictive factors of in deb-tace" by ((b)(6) university) was received from a physician via the company distributor, and concerned a (b)(6) male.No medical history and no concomitant medication were reported on an unspecified date, tace was performed for hepatocellular carcinoma (hcc) with dc bead (100-300 microm).On (b)(6) 2014, computerised tomogram (ct) scan was conducted twice and revealed massive ascites and encephalopathy.On (b)(6) 2014, ascites and encephalopathy were recovering and the patient was discharged.The physician did not assess the seriousness of the events and considered both events (ascites and encephalopathy) as probably related to dc bead treatment the company assessed both events as serious (hospitalization).Additional information received on 10-feb-2016: risk assessment: the information in this case comes from a published report in the literature.Further follow-up is being sought by btg.In this case a patient received treatment with dc beads for hepatocellular carcinoma.At an unspecified time after the procedure, the patient presented with ascites and hepatic encephalopathy.Because of the unknown interval, it is difficult to assess whether the development of these symptoms may have been related to the dc bead treatment (in which case it would have occurred due to ectopic placement of beads in normal liver tissue in addition to/or instead of the target tumor).The event could also have occurred due to natural progression of the underlying liver disease and tumor if sufficient time had passed.However, even if the event was due to ectopic bead placement, this is an known risk of the procedure currently listed in the product ifu.Accordingly, this single event does not represent a change in the low risk of this complication, and may, in fact, be related to underlying disease progression rather than dc bead treatment.- fsca: this report would not constitute the need for a field safety corrective action.These are known and documented risks of the procedure and do not constitute a change to the established benefit risk profile of the product.(b)(4).Additional information received on 08-feb-2016: on (b)(6) 2014, tace was performed for hepatocellular carcinoma (hcc) with dc bead (100-300microm) loaded with epirubicin 40mg.On (b)(6) 2014, after tace, hepatic spare ability decreased and accumulation of peritoneal fluid was observed.Albumin decreased and a diuretic was administered, but no improvement in the ascites was achieved.On an unknown date, sodium restriction was conducted but no improvement was observed.The ascites were 3l by ultrasonography (us).On an unknown date, after albumin treatment and a diuretic treatment, the ascites decreased to about 1l.On (b)(6) 2014 the patient was discharged and returned to the hospital as on outpatient.Relevant lab data were provided and added in the lab data section.Pre-tace findings: child-pugh score: 6 points; the patient presented multiple tumors, with a maximun diameter of 50mm.The patient underwent tace 4 times in total (once with product).Tace-related background: degree of embolization (rate of disappearance of the contast medium, 5 heartbeats as a reference): about 5 heartbeats; embolization site and range: s5/s8 subsegment.The reporter physician considered the ascites and encephalopathy as probably related to tace final assessment on (b)(6) 2016: no device failure has been identified as a result of these adverse events.Follow up information was requested to further investigate the events, additional information received was processed within the medwatch.It has been assessed that no corrective action is necessary at this time.The report is final.Case comment: ascites and encephalopathy are considered unlisted according to dc bead current instruction for use.The physician considered the events of ascites and encephalopathy as probably related to the use of dc bead.Although the underlying liver disease of the patient could have contributed to the event, the company also considered the events to be related to the tace procedure since this possibility cannot be excluded.This single case report does not modify the risk benefit balance of dc bead.The company is continuously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.

• Brand Name: DC BEAD
• Type of Device: HCG/KRD
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: farnham business park; weydon lane; farnham, surrey GU9 8-QL ; 4125273273
• MDR Report Key: 5366102
• MDR Text Key: 35921296
• Report Number: 3002124545-2016-00001
• 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,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• 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: 02/08/2016
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR