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

Model Number	M00570540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code relates to problem code for the reported event of blue outer sheath broken from the guidewire access port.The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex biliary rx covered stent was to be used to treat malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not too tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the blue outer sheath was separated from the guidewire access port and the stent would not deploy.The procedure was completed with another wallflex biliary rx covered 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.
Additional Manufacturer Narrative
A fully constrained wallflex biliary rx covered stent and delivery system were received for analysis.Visual examination of the returned device found the stainless steel tube was not actuated beyond its reconstrainment limit.The inner shaft was kinked and the outer sheath was detached/broken at the outer diameter: proximal exterior tube ¿ endoscope interface (near the guidewire access sheath).Functional evaluation found it was not possible to deploy the stent using the delivery system, however, it was possible to manually deploy the stent.The stent was measured and was found to be within specifications.No issues 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 excessive force during usage.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 of 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 on january 29, 2018 that a wallflex biliary rx covered stent was to be used to treat malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not too tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the blue outer sheath was separated from the guidewire access port and the stent would not deploy.The procedure was completed with another wallflex biliary rx covered 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.

• Brand Name: WALLFLEX¿ BILIARY RX STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7286384
• Report Number: 3005099803-2018-00390
• Device Sequence Number: 19127035
• Product Code: FGE
• UDI-Device Identifier: 08714729764922
• UDI-Public: 08714729764922
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 01/29/2018

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: 04/14/2019
• Device Model Number: M00570540
• Device Catalogue Number: 7054
• Device Lot Number: 20527151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1