MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD DC BEAD; HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE

Model Number 100-300 MICROMETERS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Embolism (1829); Hemorrhage/Bleeding (1888); Ulcer (2274)

Event Date 08/13/2015

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 bleeding from a gastric ulcer.Non-target embolization [device deployment issue].Case description: initial information received on 21-feb-2017 and additional information received on 24-feb-2017: this literature device report was published in the cardiovascular and interventional radiology (cirse) by hirata m.Et al., entitled "a rare complication of deb-tace: gastric ulcer caused by migration of the embolic agent through the adhesion between superficial hcc and the stomach", concerning a (b)(6) female patient.The patient's medical history included multiple hepatocellular carcinomas (hcc).The patient's concomitant medications were not reported.On an unknown date, the patient received dc bead (unknown lot number, expiration date and bead size), during a deb-tace, for multiple hccs.On an unspecified date, 9 days after the procedure, the patient experienced massive bleeding from a gastric ulcer caused by non-target embolization.Histologically, beads were thought to have passed through the adhesion between superficial hcc and the stomach.The treatment and the outcome of the events were not reported.The reporting author did not provide an assessment of the seriousness of the events.However, the reporter considered the events related to deb-tace.The company considered the event massive bleeding from a gastric ulcer as serious (medically significant), and the event non-target embolization toxicity as non-serious.Follow-up information will be requested.Case comment: gastric ulcer haemorrhage and device deployment issue are considered listed according to dc bead current reference safety information.In agreement with the assessment made by the reporter, the company considered the events gastric ulcer haemorrhage and device deployment issue as related to the use of dc bead.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 bleeding from a gastric ulcer [gastric ulcer haemorrhage], non-target embolization [device deployment issue].Case description: initial information received on 21-feb-2017 and additional information received on 24-feb-2017: this literature device report was published in the cardiovascular and interventional radiology (cirse) by hirata m.Et al., entitled "a rare complication of deb-tace: gastric ulcer caused by migration of the embolic agent through the adhesion between superficial hcc and the stomach", concerning a (b)(6) female patient.The patient's medical history included multiple hepatocellular carcinomas (hcc).The patient's concomitant medications were not reported.On an unknown date, the patient received dc bead (unknown lot number, expiration date and bead size), during a deb-tace, for multiple hccs.On an unspecified date, 9 days after the procedure, the patient experienced massive bleeding from a gastric ulcer caused by non-target embolization.Histologically, beads were thought to have passed through the adhesion between superficial hcc and the stomach.The treatment and the outcome of the events were not reported.The reporting author did not provide an assessment of the seriousness of the events.However, the reporter considered the events related to deb-tace.The company considered the event massive bleeding from a gastric ulcer as serious (medically significant), and the event non-target embolization toxicity as non-serious.Follow-up information will be requested.Follow-up information received on 07-mar-2017 and additional information received on 15-mar-2017: the reporting physician provided the patient's date of birth.It was confirmed that the patient was (b)(6) at the time of the event.Via company distributor, the reporting physician stated that this incident was already reported on 27-aug-2015.According to this new information, this case was identified to be a duplicate of (b)(4).All information in (b)(4), including the (b)(6) request, was included in (b)(4).This duplicate (b)(4) will be therefore nullified.Case comment: gastric ulcer haemorrhage and device deployment issue are considered listed according to dc bead current reference safety information.In agreement with the assessment made by the reporter, the company considered the events gastric ulcer haemorrhage and device deployment issue as related to the use of dc bead.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 SINGLE USE IMPLANTABLE MEDICAL DEVICE
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham, surrey ; UK
• 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 ; 1252 732 7
• MDR Report Key: 6375670
• MDR Text Key: 68975768
• Report Number: 3002124545-2017-00009
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100-300 MICROMETERS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• 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): Other
• Patient Age: 68 YR