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

Model Number	H965430500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).The complainant indicated that the suspect device remains implanted 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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a wallstent biliary uncovered stent had been implanted to treat a periampullary malignant stricture in the mid common bile duct during a biliary stent placement procedure performed on (b)(6) 2018.The patient's anatomy was not tortuous and was not dilated prior to stent placement, and the patient was stable following the procedure.On (b)(6) 2019, according to the complainant, the patient developed cholangitis post procedure.The stent remains implanted.No information has been received regarding the cause of the cholangitis, how it was treated or resolution of the cholangitis.Reportedly, the patient has been admitted to a different hospital in a different state and the physician was unable to provide additional details, despite efforts.

• Brand Name: WALLSTENT BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8529114
• Report Number: 3005099803-2019-02007
• Device Sequence Number: 1884392
• Product Code: JCT
• UDI-Device Identifier: 08714729204671
• UDI-Public: 08714729204671
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K982184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2020
• Device Model Number: H965430500
• Device Catalogue Number: 43050
• Device Lot Number: 0022255750
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/18/2019
• 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: Hospitalization