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

Model Number	H965430600
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: a fully constrained wallstent biliary uncovered stent and delivery system were received for analysis.Visual examination of the returned device found bends in the clear outer sheath at the distal end.The inner member was kinked and was found exiting the outer sheath at the proximal end.The inner shaft tip was pulled into the outer sheath.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received, however the stent could be deployed by cutting the outer sheath and pulling the inner member distally.Visual analysis of the deployed stent found uncrossed wires at one end.The stent and delivery system was measured to be within specifications.There were no other issues noted with the device.The damages noted with the device were consistent with the application of excessive force during use.The investigation concluded that the observed failures were likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary uncovered stent was to be used to treat a biliary stricture caused by hilar cholangiocarcinoma during a planned endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was dilated with dilatation balloon prior to stent placement.According to the complainant, during the procedure, the stent failed to deploy and the inner shaft kinked out of the guidewire access sheath.The procedure was not completed as same device was unavailable.An ercp was performed on another day and a plastic stent was placed.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.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the stent has uncrossed wires at one end.

• Brand Name: WALLSTENT¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7426905
• Report Number: 3005099803-2018-01029
• Device Sequence Number: 11148933
• Product Code: FGE
• UDI-Device Identifier: 08714729204688
• UDI-Public: 08714729204688
• 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): 03/26/2018

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: 06/29/2019
• Device Model Number: H965430600
• Device Catalogue Number: 43060
• Device Lot Number: 20830752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 62