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

Model Number	M00574720
Medical Device Problem Codes	Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Good faith effort attempts were made to try and retrieve the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that intervention was required.The patient presented with a large pancreatic tumor with a tortuous, tightly stenosed biliary tree.A 10mmx40mm wallflex biliary transhepatic stent was selected for treatment via trans biliary approach.During the procedure, the lesion was not pre-dilated and difficulty crossing the lesion was noted.During stent deployment, difficulty was noted and the stent deployed with less than 1cm out of the sheath, and the majority of the stent remaining within the sheath.The stent was recaptured, and both the sheath and delivery system were removed as a system.The patient was moved to gastroenterology (gi) to attempt stent placement; however, this was unsuccessful, and the procedure was prolonged.The procedure was subsequently cancelled, and a drainage catheter was placed for palliative purposes and the procedure was rescheduled.There were no patient complications as a result of this event.

• Brand Name: WALLFLEX? BILIARY TRANSHEPATIC
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 25236187
• Report Number: 2124215-2026-27304
• Device Sequence Number: 5135641
• Product Code: FGE
• UDI-Device Identifier: 08714729799368
• UDI-Public: (01)08714729799368
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K112543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00574720
• Device Catalogue Number: M00574720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 06/30/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown