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

Model Number 100-300UM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Fever (1858); Thrombosis (2100); Vomiting (2144); Test Result (2695)

Event Date 08/27/2014

Event Type  Injury  

Event Description

This initial report concerns a(b)(6) year old female pt and was received from a user facility via a partner organization on (b)(6) 2014.The pt's concomitant diseases include autoimmune (b)(6), diabetes mellitus, insomnia, constipation, gastritis and reflux esophagitis.On (b)(6) 2014, the pt received tace with drug-eluting dc bead (100-300um) 1 vial loaded with 40mg of epirubicin.In (b)(6) 2014, between the treatment date and the following day, the pt experienced vomiting and abdominal pain.On (b)(6) 2014, the pt recovered from vomiting.Between (b)(6) 2014, the pt developed platelets decreased, ast increased, alt increased and bilirubin elevated.On (b)(6) 2014, the pt recovered from abdominal pain.On (b)(6) 2014, the pt developed pyrexia.The reporter considered the events vomiting, abdominal pain, platelets decreased, ast increased, alt increased, bilirubin elevated and pyrexia as non-serious.On (b)(6) 2014, the pt developed portal vein thrombosis which the reporter considered as serious event.The reporter stated that the pt was given danapaid n for thrombolytic therapy for portal vein thrombosis.On (b)(6) /2014, the pt was recovering from platelets count decreased and the pt recovered from ast increased, alt increased and bilirubin elevation.On (b)(6) 2014, the pt recovered from pyrexia.On (b)(6) 2014, thrombolytic therapy was discontinued as thrombus resided even though there was reduction of thrombus.At the time of reporting the event of portal vein thrombosis had not resolved.The reporting physician stated that the events protal vein thrombosis was possibly related to dc bead and platelets decreased, pyrexia, vomiting, abdominal pain, ast increase, alt increase and bilirubin elevation were probably related to dc bead.

Manufacturer Narrative

Dc bead was reported to have been used in the treatment of this pt.The equivalent product, lc bead, is available in the usa an is indicated for the treatment of hypervascular tumours and avms.The use of epirubicin with dc bead is considered off-label use.The device has not been sent to the mfr for eval, batch review will not be possible for this case as the reporter does not specify lot number.Given the case info currently available, it is difficult for the mfr to assess if product malfunction/deficiency has occurred.Medical assessment: this pt developed several complications after deb-tace treatment.These included abdominal pain, abnormal left's, increased bilirubin, fever and portal vein thrombosis.All resolved except the protal vein thrombosis.While these events could be due to the pt's underlying disease, the temporal relationship makes it impossible to exclude that they were due to device malfunction or, more likely, user error.This event is accordingly medically reportable.This event is currently under investigation by the mfr and the conclusions of this investigation will be communicated as a follow-up report.

• Brand Name: DC BEAD
• Type of Device: EMBOLIC AGENT, HCG/KRD
• Manufacturer (Section D): BIOCOMPATIBLES U.K. LIMITED; weydon ln; farnham business park; farnham, surrey england GU9 8QL; UK GU9 8QL
• Manufacturer Contact: weydon ln; farnham busness park; farnham, surrey england GU9 8-QL ; 252732732
• MDR Report Key: 4320951
• MDR Text Key: 5207296
• Report Number: 3002124545-2014-00031
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100-300UM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2014
• 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
• Treatment: VOGLIBOSE; PENTAZOCINE; IOMEPROL 300MG/ML; EPIRUBICIN HYDROCHLORIDE 40MG; MAGNESIUM OXIDE; POLAPREZINC; PREDNISOLONE ACETATE.; SENNOSIDE; CEFAZOLIN SODIUM; GRANISETRON HYDROCHLORIDE; HYDROXYZINE PAMOATE; TRIAZOLAM; RABEPRAZOLE SODIUM; LIDOCAINE; URSODEXYCHOLIC ACID
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 69