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

Model Number	M00570640
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.
Event or Problem Description
It was reported to boston scientific that a wallflex biliary rx uncovered stent was to be implanted in the blie duct to treat a short biliary stricture due to pancreatic cancer during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was fully deployed; however, the distal part of the stent did not expand.The stent remains in place, and the physician has no plan to remove it at this time, opting instead to wait for the bilirubin levels to decrease.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Block h11: the investigation was closed without a product return.However, a media inspection was conducted using a photo provided by the complainant.Based on the media analysis, the stent was located within the patient's anatomy and showed signs of expansion issues.Product analysis confirmed the reported event of stent failure to expand based on the media analysis.However, there is not enough evidence to determine whether the reported event was due to the physician's technique, anatomical challenges, or a device malfunction.Due to the lack of evidence and without proper evaluation of the complaint device, the most probable root cause of the reported event is cause not established.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific that a wallflex biliary rx uncovered stent was to be implanted in the blie duct to treat a short biliary stricture due to pancreatic cancer during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was fully deployed; however, the distal part of the stent did not expand.The stent remains in place, and the physician has no plan to remove it at this time, opting instead to wait for the bilirubin levels to decrease.There was 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21873448
• Report Number: 3005099803-2025-01685
• Device Sequence Number: 8640672
• Product Code: FGE
• UDI-Device Identifier: 08714729756231
• UDI-Public: (01)08714729756231(17)250702(10)31939318
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 07/02/2025
• Device Model Number: M00570640
• Device Catalogue Number: M00570640
• Device Lot Number: 0031939318
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/12/2025
• Date Device Manufactured: 07/03/2023
• 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