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

Model Number	M00570520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A fully constrained wallflex biliary rx covered stent and delivery system was returned for analysis.Visual evaluation of the returned device found that the outer sheath was broken at the outer diameter: proximal exterior tube - endoscope interface (at the proximal end of the guidewire access sheath), the stainless steel tube was not actuated beyond its reconstrainment limit of the inner shaft was found kinked.A functional examination found that it was not possible to deploy the stent using the delivery system as received due to the break in the sheath, however it was possible to deploy the stent.No issues were noted with the stent.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 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 covered stent was to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, resistance was noted and the stent would not open.Reportedly, the physician and the nurse heard a snap.The stent was removed from the patient and the procedure was completed with another of the same device.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 ¿ endoscope interface (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: 7148933
• Report Number: 3005099803-2017-03932
• Device Sequence Number: 19109737
• Product Code: FGE
• UDI-Device Identifier: 08714729764908
• UDI-Public: 08714729764908
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 12/11/2017

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: 09/16/2018
• Device Model Number: M00570520
• Device Catalogue Number: 7052
• Device Lot Number: 19727634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1