MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	H965430500
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device has been contaminated 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)(4) 2018 that a wallstent biliary uncovered stent was to be used to treat a stricture in the common bile duct due to cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, there was difficulty inserting a guidewire through the delivery system though a sterile saline solution was used to flush the delivery system.The papilla was cut to gain access in the bile duct (papillotomy).The wallstent delivery system was then advanced to the target area and the stent was attempted to be deployed.However, there was difficulty deploying the proximal end of the stent.Reportedly, the wire order in the opened loop end of the stent formed an irregular shape.The stent was removed with a snare and the procedure was completed with another wallstent biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the end of the procedure was reported to be stable.

• Brand Name: WALLSTENT¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7468744
• Report Number: 3005099803-2018-01359
• Device Sequence Number: 1195896
• Product Code: FGE
• UDI-Device Identifier: 08714729204671
• UDI-Public: 08714729204671
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K982184
• 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): 04/04/2018

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: 09/04/2019
• Device Model Number: H965430500
• Device Catalogue Number: 43050
• Device Lot Number: 21090033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/27/2018
• 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