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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A wallflex biliary rx covered stent and delivery system was received for analysis.The stent was received fully constrained by the outer sheath on the delivery system, however the stainless steel shaft of the handle was noted to be past the reconstrainment limit.Visual examination of the returned device found the outer sheath broken at the proximal end of the guidewire access sheath.The inner shaft was also kinked.No issues were noted with the stent and no other issues were noted with the device.The noted damages to the device were likely due to anatomical or procedural factors, encountered during stent deployment, which limited the performance of the device.Therefore, the most probable root cause of the 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 fully covered stent was to be used to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date.According to the complainant, during the procedure, the stent failed to deploy.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the outer sheath was broken 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: 7007878
• Report Number: 3005099803-2017-03327
• Device Sequence Number: 1130475
• Product Code: FGE
• UDI-Device Identifier: 08714729764908
• UDI-Public: 08714729764908
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/16/2017

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: 06/02/2019
• Device Model Number: M00570520
• Device Catalogue Number: 7052
• Device Lot Number: 0020720785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1