MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DC BEAD 100-300 MICRON; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number DC2J103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Disseminated Intravascular Coagulation (DIC) (1813); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/18/2023

Event Type  Death  

Manufacturer Narrative

H6 patient codes: e2402 refers to tumor lysis syndrome.

Event Description

It was reported that the patient had a medical history of hepatitis c, hepatocellular carcinoma (hcc), right liver lobe resection, c-tace due to recurrence of hcc, rectal cancer, appendicitis, and hypertension.The referenced dc beads were selected for use in a hepatic artery embolization procedure performed on (b)(6) 2023.The tumor diameter was reported to be 12 cm, and the tumor had grown rapidly over a period of 6 months.A total of 100-300-micron dc beads were drug loaded with epirubicin and injected with contrast agent to full stasis.The dc beads injection volume was 2 ml.No backflow of dc beads, or leakage of dc beads into other vessels, occurred during the procedure.Two days after the procedure, the patient's condition changed suddenly.The patient was diagnosed with tumor lysis syndrome, developed disseminated intravascular coagulation (dic), and died six days after the procedure.

Manufacturer Narrative

H6 patient codes: e2402 refers to tumor lysis syndrome.Updated aware date.

Event Description

It was reported that the patient had a medical history of hepatitis c, hepatocellular carcinoma (hcc), right liver lobe resection, c-tace due to recurrence of hcc, rectal cancer, appendicitis, and hypertension.The referenced dc beads were selected for use in a hepatic artery embolization procedure performed on (b)(6) 2023.The tumor diameter was reported to be 12 cm, and the tumor had grown rapidly over a period of 6 months.A total of 100-300-micron dc beads were drug loaded with epirubicin and injected with contrast agent to full stasis.The dc beads injection volume was 2 ml.No backflow of dc beads, or leakage of dc beads into other vessels, occurred during the procedure.Two days after the procedure, the patient's condition changed suddenly.The patient was diagnosed with tumor lysis syndrome, developed disseminated intravascular coagulation (dic), and died six days after the procedure.

• Brand Name: DC BEAD 100-300 MICRON
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17932639
• MDR Text Key: 325632002
• Report Number: 2124215-2023-56089
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DC2J103
• Device Catalogue Number: DC2J103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• 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): Death