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

Model Number	M00572280
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been discarded 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 (b)(6) 2019 that an endoscopic epic biliary stent was to be used to treat a malignant stricture in the biliary/ hepatic duct during an endoscopic retrograde cholangiopancreatography with stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous, heavily strictured and was not dilated prior to stent placement.According to the complainant, during the procedure, the physician tried to deploy the stent by clicking the thumbwheel; however, the stent stayed in the sheath and did not deploy.The physician then pulled the handle to deploy the stent, and the stent still failed to deploy.The stent and delivery system was pulled out from the biliary duct and suddenly the stent deployed in the duodenum.The stent was removed with rat tooth forceps and the procedure was discontinued.There were no patent complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be okay.According to the physician, it seemed like the stent would not deploy because it didn't have room in the duct due to it being heavily structured and tortuous.

• 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: 8741490
• Report Number: 3005099803-2019-03194
• Device Sequence Number: 11272728
• Product Code: FGE
• UDI-Device Identifier: 08714729896906
• UDI-Public: 08714729896906
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2020
• Device Model Number: M00572280
• Device Catalogue Number: 7228
• Device Lot Number: 0021862484
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention