MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR; AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS

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

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Inflammation (1932); Nausea (1970); Vomiting (2144); Weakness (2145); Burning Sensation (2146); Chills (2191); Discomfort (2330)

Event Date 07/01/2016

Event Type  Injury  

Event Description

It was reported that patient complications occurred.The patient experienced heavy bleeding after childbirth.Contour embolization particles were introduced into the patient via the left uterine artery into the uterus.This left the uterine artery completely submerged.Strong pain was felt in the left lower abdomen, always three hours before a bowel movement, until the bowel movement.Burning pain was also felt in the buttocks and genital area which was more uncomfortable in the heat and with stronger movement.The patient reported further symptoms of inflammation of the colon wall with local abdominal pain, gastrointestinal discomfort, nausea, vomiting, loose stools, loss of appetite, weakness, cold, and cough in the morning.The symptoms were reported as not resolved and ongoing.

• Brand Name: CONTOUR
• Type of Device: AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC LIMITED; business & technology park; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9310164
• MDR Text Key: 166014176
• Report Number: 2134265-2019-13656
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 65