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

Model Number	M00572290
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that an epic biliary stent was to be used to treat a malignant stricture due to bile duct cancer during a biliary stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous.According to the complainant, during the procedure, the stent was attempted to be deployed in the lower part of the bile duct.The handle was rotated but the stent could not be deployed.Reportedly, the stent suddenly began to deploy, and a long part of the stent came out in the duodenum.The stent was removed from the patient and another epic biliary 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: 8039543
• Report Number: 3005099803-2018-61170
• Device Sequence Number: 19148029
• Product Code: FGE
• UDI-Device Identifier: 08714729896913
• UDI-Public: 08714729896913
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2019
• Device Model Number: M00572290
• Device Catalogue Number: 56705
• Device Lot Number: 0021472835
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1