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

Model Number 100-300UM

Device Problems High Test Results (2457); Output Problem (3005)

Patient Problem Reaction (2414)

Event Date 08/20/2014

Event Type  Injury  

Event Description

This initial report concerns a (b)(6) year old male pt and was received from a user facility via a partner organization on (b)(6) 2014.The pt's concomitant diseases include diabetes mellitus and chronic renal failure.On (b)(6) 2014, the pt underwent tace procedure with drug-eluting dc bead (100-300um) 1 vial loaded with 50 mg of epirubicin.It was reported that gelpart (porous gelatin particles) was also used as part of the procedure.In (b)(6) 2014 (between (b)(6) 2014), the pt developed vagal reaction, and vagal reaction resolved on the same day (between (b)(6) 2014).The reporter stated that the event was considered non-serious.On the (b)(6) 2014 the pt experienced an increase in ast, alt and ldh.The laboratory values were not provided but the reporter classified the increase as serious adverse events.The pt was reported to be recovering from the event of ast increase on the (b)(6) 2014 and the events of alt and ldh increase were assessed as resolving on the (b)(6) 2014.The reporting physician assessed the event of vagel reaction as possibly related to dc bead and the events of increased ast, alt, ldh as 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 and is indicated for the treatment of hypervascular tumors and avm's.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: pt experienced abnormal lft's that were felt to constitute a serious adverse event by the reporting physician soon after deb-tace.These abnormalities were resolving.While abnormal lft's are an expected complication of this procedure, the magnitude of elevation that led the reporter to label this event as serious could be consistent with user error (eg inadvertent placement of embolic beads in more normal liver tissue than is usual) hence 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; chapman house, farnham bus.; park, weydon ln; farnham, surrey GU9 8QL; UK GU9 8QL
• Manufacturer Contact: chapman house, farnham bus.; park, weydon ln; farnham, surrey GU9 8-QL ; 252732732
• MDR Report Key: 4320956
• MDR Text Key: 5206764
• Report Number: 3002124545-2014-00032
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• 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
• 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
• 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: ATROPINE SULFATE HYDRATE (0.25MG WAS ADMINISTERED; AND TAURINE; LIDOCAINE,; INTRACENOUSLY),; EPIRUBICIN HYDROCHLORIDE 40MG,; CEFAZOLIN SODIUM,; IOMEPROL 350MG/ML,; GRANISETRON HYDROCHLORIDE,; MAGNESIUM OXIDE,; PROHEPARUM,; PENTAZOCINE,; EPIRUBICIN HYDROCHLORIDE 50MG,; URSODEOXYCHOLIC ACID,
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 52