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

Model Number	M00570660
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result a fully constrained wallflex biliary rx uncovered stent and delivery system were returned for analysis.The stent was received fully covered by the outer sheath.Visual examination of the returned device found the outer sheath was detached/broken at the outer diameter: proximal exterior tube ¿ endoscope interface (proximal end of the gas section).The inner member near the proximal end of the guidewire access sheath (gas) section was found kinked.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received; however, the stent was deployed manually by gripping the outer sheath and pulling the tip distally.There were no issues with the stent and no other issues with the delivery system were noted.The damages noted with the returned device were consistent with the application of excessive force during use.Taking all available information into consideration, the investigation concluded that the observed failures and the reported event 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 wallflex biliary rx uncovered stent was to be used to treat a malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was tight and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent would not deploy in the common bile duct.The stent was fully covered by the outer sheath when removed from the patient.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 fine.Note: this event has been deemed an mdr reportable event based on investigation results which revealed that the outer sheath was detached/broken at the outer diameter: proximal exterior tube ¿ endoscope interface (proximal end of the gas section).

• Brand Name: WALLFLEX¿ BILIARY RX STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7726443
• Report Number: 3005099803-2018-02413
• Device Sequence Number: 1452195
• Product Code: FGE
• UDI-Device Identifier: 08714729759287
• UDI-Public: 08714729759287
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/06/2018

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: 11/16/2019
• Device Model Number: M00570660
• Device Catalogue Number: 7066
• Device Lot Number: 21398902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1