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

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Hematoma (1884); Hemorrhage/Bleeding (1888); Test Result (2695)

Event Date 05/11/2015

Event Type  Injury  

Event Description

Bleeding occurred from the tumor feeding artery ab [tumour haemorrhage].Postoperative anaemia [anaemia postoperative].Intratumoral hematoma [hepatic haematoma].Case description: initial info received on (b)(6) 2015: the medical device report was received by a physician via company distributor and it concerned a (b)(6) male pt.Pt's medical history included hypertension and alcoholic cirrhosis.Concomitant medication not reported.On (b)(6) 2015, the pt underwent transcatheterchemoembolization (tace) using drug-eluting dc bead (2ml of beads) loaded with 50mg of farmorubicin (epirubicin hydrochloride).Tumor hemorrhage developed after treatment.Bleeding occurred from the tumor artery a8, the pt received gelpart (porous gelatin particle) for hemostasis.Postoperative anaemia continued to progress until (b)(6) 2015 and pt's hemoglobin level was 6.9 (unit and normal range not provided).On (b)(6) 2015, the pt underwent a ct-scan showing a intratumoral hematoma.He received a blood transfusion that improved his hemoglobin level to 7.7.On (b)(6) 2015, the outcome of the intratumoral hemorrhage was unk.On (b)(6) 2015, pt's hemoglobin level improved to 8.6 and he was discharged from the hospital.The reporting physician considered tumor haemorrhage as not related to dc bead.The reporting physician considered the intrahepatic hemorrhage related to tace procedure.

Manufacturer Narrative

Dc bead with epirubicin hydrochloride 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 avms.The use of dc bead with epirubicin hydrochloride is considered off-label use.

Manufacturer Narrative

Dc bead with epirubicin hydrochloride 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.The use of dc bead with epirubicin hydrochloride is considered off-label use.

Event Description

Bleeding occurred from the tumor feeding artery a8 [tumour haemorrhage].Postoperative anaemia [anaemia postoperative].Intratumoral hematoma [hepatic haematoma].Case description: initial information received on (b)(6) 2015: the medical device report was received by a physician via company distributor and it concerned a (b)(6) male patient.Patient's medical history included hypertension and alcoholic cirrhosis.Concomitant medication not reported.On (b)(6) 2015 the patient underwent transcatheter chemoembolization (tace) using drug-eluting dc bead (2ml of beads) loaded with 50mg of farmorubicin (epirubicin hydrochloride).Tumor hemorrhage developed after treatment.Bleeding occurred from the tumor artery a8, the patient received gel part (porous gelatin particle) for hemostasis.Postoperative anaemia continued to progress until (b)(6) 2015 and patient's hemoglobin level was 6.9 (unit and normal range not provided).On (b)(6) 2015 the patient underwent a ct-scan showing a intratumoral hematoma.He received a blood transfusion that improved his hemoglobin level to 7.7.On (b)(6) 2015, the outcome of the intratumoral hemorrhage was unknown.On (b)(6) 2015, patient's hemoglobin level improved to 8.6 and he was discharged from the hospital.The reporting physician considered tumor haemorrhage as not related to dc bead.The reporting physician considered the intrahepatic hemorrhage related to tace procedure.Case comment: tumor hemorrhage is listed according to the current dc bead instruction for use.Anaemia postoperative and intrahepatic hematoma are not listed according to the current dc bead instruction for use.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.Final assessment received on 22-dec-2015: the company considers the events of tumor haemorrhage, anemia postoperative and hepatic haematoma as related to dc bead.No further follow up information is expected.No device failure has been identified as a result of this adverse event.It has been assessed that no corrective action is necessary at this time.This report is considered final.The case is closed.

• 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 ; 41252 732
• MDR Report Key: 4890764
• MDR Text Key: 6072632
• Report Number: 3002124545-2015-00040
• 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: Other,Foreign,Health Professional,Distributor,distributor,forei
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2015
• 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: 78 YR
• Patient Weight: 55