MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ BILIARY RX STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570620
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: a fully constrained wallflex biliary rx stent and delivery system was received for analysis.Visual examination of the returned device found the proximal end of the guidewire access sleeve was detached from the outer sheath and the inner catheter was severely kinked.The stent was not deployed.This damage confirms the complaint as reported.The stent was able to be deployed manually without resistance.No other issues were identified during the product analysis.The noted damage is consistent with the application of excessive force to the delivery system.As a result of the break in the delivery system, the physician was unable to retract the exterior tube to allow stent deployment.The investigation concluded that the observed failures are 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) revealed no non-conforming events or deviations.A search of the complaint database confirmed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx uncovered stent was to be used to treat a malignant stricture in the proximal common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent failed to deploy.The procedure was completed with another wallflex biliary rx 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 fine.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the proximal end of the guidewire access sleeve was detached from the outer sheath.

• Brand Name: WALLFLEX¿ BILIARY RX STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6618784
• Report Number: 3005099803-2017-01694
• Device Sequence Number: 738828
• Product Code: FGE
• UDI-Device Identifier: 08714729759263
• UDI-Public: (01)08714729759263(17)20181124(10)20003492
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140630
• 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): 05/16/2017

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: 11/24/2018
• Device Model Number: M00570620
• Device Catalogue Number: 7062
• Device Lot Number: 20003492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR