MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00572330
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484); Activation, Positioning or Separation Problem (2906); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the complainant, the suspect device was thrown out and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on january 21, 2019 that an epic biliary stent was to be used to treat a malignant stricture in the common bile duct due to cholangiocarcinoma (cca) during an endoscopic retrograde cholangiopancreatography with stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the delivery catheter kinked between the elevator and papilla, which caused difficulty in placing the stent.Reportedly, the stent was partially deployed and could not finish the deployment.The stent was pulled back through the scope but, the stent got caught in the scope, and was prematurely deployed inside the scope.The stent and the scope were removed and a wallflex biliary uncovered stent was placed to complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: EPIC BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8341390
• Report Number: 3005099803-2019-00713
• Device Sequence Number: 1717702
• Product Code: FGE
• UDI-Device Identifier: 08714729896951
• UDI-Public: 08714729896951
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2019
• Device Model Number: M00572330
• Device Catalogue Number: 56705
• Device Lot Number: 0021498101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1