MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOZENE MICROSPHERES; EMBOLIC DEVICE

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

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 07/01/2018

Event Type  Injury  

Manufacturer Narrative

Event date: no event date was provided.Therefore the event date was populated with the first date of the month of the aware date.Initial reporter phone number: (b)(6).

Event Description

It was reported that the patient experienced a gastrointestinal (gi) bleed, dark feces, and some challenges with the biliary duct.Embozene microspheres (40 um) was selected for use during a liver embolization/bland-tace procedure for a patient with liver cancer.No malfunction was reported to have occurred during the procedure.However, afterwards, the doctor reported that the patient had an adverse event of gi bleed, dark feces and some challenges with the biliary duct; believed to be due to the embozene 40 um.No other complications were reported.

• Brand Name: EMBOZENE MICROSPHERES
• Type of Device: EMBOLIC DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7795112
• MDR Text Key: 117561406
• Report Number: 2134265-2018-60053
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• 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