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

Model Number	M00570620
Medical Device Problem Codes	Entrapment of Device (1212); Problem with Sterilization (1596)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(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 procedures involving one wallflex biliary stent.It was reported to boston scientific corporation on november 10, 2020 that a wallflex biliary rx uncovered stent was to be implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, resistance was encountered while advancing the delivery system through the scope.The device was removed from the scope and another wallflex biliary uncovered stent was implanted to complete the procedure.Reportedly, later that day, the same non boston scientific scope was reprocessed and was used in a different procedure.During the procedure, a snare was advanced through the scope but resistance was encountered and noted a deployed wallflex biliary stent from the previous procedure was coming out from the distal end of the scope.The physician then removed the scope and pulled the stent out of the scope.Reportedly, the previously advanced wallflex biliary rx uncovered stent was prematurely deployed from the catheter inside the scope during removal and remained in the scope during the reprocessing cleaning process.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: 10943302
• Report Number: 3005099803-2020-05772
• Device Sequence Number: 3419375
• Product Code: FGE
• UDI-Device Identifier: 08714729759263
• UDI-Public: 08714729759263
• 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): 12/03/2020

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 Model Number: M00570620
• Device Catalogue Number: 7062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1