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	09/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A wallstent biliary stent and delivery system was returned for analysis not deployed.Visual evaluation found the clear outer sheath was significantly bent and the blue outer sheath was detached from valve body, confirming the reported complaint.A fillet of glue on the valve body and what appears to be glue residue on the stainless steel tube was visible.The inner shaft was significantly kinked and the stainless steel tube handle was slightly bent.The wires at the distal end of the stent were bent and uncrossed.It was possible to deploy the stent but force was required.The damage noted to the device during analysis is consistent with the application of excessive force during usage most probably due to anatomical or procedural factors encountered during the procedure.Therefore, the most probable root cause for this complaint is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2016 that a wallstent biliary stent was to be used in the common bile duct during a biliary metal stenting procedure performed on (b)(6) 2016.Reportedly, the patient¿s anatomy was not tortuous and had not been dilated prior to placement.During the procedure, the outer sheath detached from the handle.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 conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation results; stent was damaged with the wires at the distal end of the stent bent and uncrossed.

• Brand Name: WALLSTENT¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6195696
• Report Number: 3005099803-2016-03915
• Device Sequence Number: 13720766
• Product Code: FGE
• UDI-Device Identifier: 08714729204671
• UDI-Public: (01)08714729204671(17)20171208(10)18715614
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/30/2016

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: 12/08/2017
• Device Model Number: H965430500
• Device Catalogue Number: 43050
• Device Lot Number: 18715614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2016
• Initial Report FDA Received Date: 12/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1