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

Model Number	M00570730
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) for the investigation result of sheath broken at the proximal end of the guidewire access sheath.A wallflex biliary rx fully covered stent and delivery system was returned for analysis.Visual examination of the returned device found that the stent was received fully covered by the outer sheath and the stainless steel tube was not actuated beyond its reconstrainment limit, and the inner shaft was kinked at places.The outer sheath was found broken at the outer diameter: proximal exterior tube ¿ endoscope interface (at the proximal end of the guidewire access sheath).Functional examination found that it was not possible to deploy the stent using the delivery system as received, however it was possible to manually deploy the stent.No issues were noted with the stent and no other issues were noted with the device.The damages noted with the device were consistent with the application of force during attempted 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 for this complaint 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 wallflex biliary rx partially covered stent was used to treat a 3 cm malignant stricture in the common bile duct during a 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 physician started to deploy the stent.However, during stent deployment, the physician heard a ¿knack¿ sound and the stent failed to deploy.The physician removed the stent from the patient and the procedure was completed with another wallflex 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.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the outer sheath was broken at the outer diameter: proximal exterior tube (at the proximal end of the guidewire access sheath).

• Brand Name: WALLFLEX¿ BILIARY RX STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7186732
• Report Number: 3005099803-2018-00027
• Device Sequence Number: 73156
• Product Code: FGE
• UDI-Device Identifier: 08714729759324
• UDI-Public: 08714729759324
• Combination Product (Y/N): N
• PMA/510(K) Number: K140630
• 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): 12/22/2017

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: 09/18/2019
• Device Model Number: M00570730
• Device Catalogue Number: 7073
• Device Lot Number: 21144586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR