MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CONTOUR PVA MICROSPHERES; AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS

Model Number UNK90

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

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

Reported via journal article.It was reported that biloma occurred.In a study to compare the efficacy of right portal vein embolization using particles only versus particle and additional central plug and/or coil.Extrahepatic biloma after portal vein embolization occurred.This was treated with ct-guided percutaneous drainage and did not prohibit the planned resection.

Manufacturer Narrative

Literature citation: geisel, dominik, et.Al."improved hypertrophy of future remnant liver after protal vein embolization with plugs, coils and particles"; cardiovascular interventional radiology (2014) 37:1251-1258.It is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: CONTOUR PVA MICROSPHERES
• Type of Device: AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4502350
• MDR Text Key: 5333520
• Report Number: 2134265-2015-00424
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• PMA/PMN Number: K030966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK90
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2015
• 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): Required Intervention