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

Model Number	M00570650
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf impact code f1001 captures the reportable event of cancelled/rescheduled - post sedation.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx uncovered stent was to be implanted to treat malignant biliary stricture during an endoscopic retrograde cholangiopancreatography ercp metal stenting procedure performed on (b)(6), 2025.The patient anatomy was dilated prior to stent placement during the procedure, while passing the stent through the stricture the sheath became kinked.The procedure was cancelled/ rescheduled.There was no patient complications reported as a result of this event.Note: a photo of the complaint device was provided, showing the outer blue sheath was kinked.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of cancelled/rescheduled - post sedation.Block h11: the wallflex biliary rx uncovered stent and its delivery system were not returned for analysis; therefore, a technical evaluation could not be conducted.A media inspection of a photo provided by the complainant revealed that the blue outer sheath appeared to be kinked.However, due to insufficient evidence and the inability to properly evaluate the device, the most probable causes contributing to the event remain undetermined.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx uncovered stent was to be implanted to treat malignant biliary stricture during an endoscopic retrograde cholangiopancreatography ercp metal stenting procedure performed on (b)(6) 2025.The patient anatomy was dilated prior to stent placement.During the procedure, while passing the stent through the stricture the sheath became kinked.The procedure was cancelled/ rescheduled.There was no patient complications reported as a result of this event.Note: a photo of the complaint device was provided, showing the outer blue sheath was kinked.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of cancelled/rescheduled - post sedation.Block h11: a wallflex biliary rx stent was returned for analysis.Visual examination revealed that the blue outer sheath was bent and kinked.Also, a photo provided by the complainant showed that the blue outer sheath was kinked.Product analysis confirmed the reported event of sheath kinked.This event was mostly due to procedural factors such as lesion characteristics, handling of the device, technique used by the physician (force applied) could have resulted in the damages encountered in the device.For the reported event of cancelled/rescheduled - post sedation/sedation unknown, this cannot be confirmed as this happened during the procedure and there is no objective evidence or descriptive information available to establish the cause of the reported event.Based on all available information, the selected most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx uncovered stent was to be implanted to treat malignant biliary stricture during an endoscopic retrograde cholangiopancreatography ercp metal stenting procedure performed on (b)(6) 2025.The patient anatomy was dilated prior to stent placement during the procedure, while passing the stent through the stricture the sheath became kinked.The procedure was cancelled/ rescheduled.There was no patient complications reported as a result of this event.Note: a photo of the complaint device was provided, showing the outer blue sheath was kinked.

• Brand Name: WALLFLEX? BILIARY
• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22373736
• Report Number: 3005099803-2025-02962
• Device Sequence Number: 18149057
• Product Code: FGE
• UDI-Device Identifier: 08714729758150
• UDI-Public: (01)08714729758150(17)250625(10)31893060
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2026

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: 06/25/2025
• Device Model Number: M00570650
• Device Catalogue Number: M00570650
• Device Lot Number: 0031893060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 07/04/2025; 02/10/2026
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/30/2025; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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
• Patient Sex: Unknown