MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX ¿ DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number	M00565010
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 enteral duodenal stent was to be used during an endoscopic retrograde cholangiopancreatography (ercp) with duodenal stent placement procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the stent was prematurely deployed outside the scope.The procedure was completed with a different size of wallflex enteral duodenal 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.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex enteral duodenal stent was to be used during an endoscopic retrograde cholangiopancreatography (ercp) with duodenal stent placement procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the stent was prematurely deployed outside the scope.The procedure was completed with a different size of wallflex enteral duodenal 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 deployed wallflex duodenal stent and delivery system were received for analysis.Visual examination of the returned device found the stainless steel tube was severely kinked.The stent was measured to be within specifications.There were no issues noted with the stent.No other issues with the device were noted during the product analysis.The damage noted with the device was consistent with the application of excessive force being applied to the device.The investigation concluded that the observed failure 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) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database revealed that no other similar complaints exist for the specified lot.

• Brand Name: WALLFLEX ¿ DUODENAL
• Common Device Name: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7302757
• Report Number: 3005099803-2018-00585
• Device Sequence Number: 1483810
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K062750
• 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): 02/06/2018

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: 08/21/2019
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 0021035803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1