MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570730
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed, and will not be returned for evaluation, therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-04564 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2020, that a wallflex biliary rx partially covered stent was to be implanted to treat a stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient anatomy was tight, and was attempted to be dilated using a hurricane balloon prior to stent placement.According to the complainant, during the procedure, while advancing the stent through the scope, the wallflex biliary rx partially covered stent (the subject of mfr.Report # 3005099803-2020-04564) deployed prematurely inside the scope without manipulation.The stent was removed from the patient with the scope.A second wallflex biliary rx partially covered stent (the subject of this report) was attempted to be implanted, however, similarly, the stent prematurely deployed in the scope.The stent was removed from the patient with the scope, and the procedure was completed with the another wallflex biliary stent.Reportedly, it was determined that the duodenal scope was likely to be defective and may have caused the stent's premature deployment within the scope.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10671812
• Report Number: 3005099803-2020-04572
• Device Sequence Number: 2744517
• Product Code: FGE
• UDI-Device Identifier: 08714729759324
• UDI-Public: 08714729759324
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

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: 10/21/2021
• Device Model Number: M00570730
• Device Catalogue Number: 7073
• Device Lot Number: 0024636064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1