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

Model Number	M00570640
Medical Device Problem Codes	Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0180104 captures the reportable event of device - foreign material present in device.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary uncovered stent was to be implanted to treat a bile duct tumor during an endoscopic retrograde cholangiopancreatography procedure (ercp), with endoscopic nasobiliary drainage procedure (enbd) and endoscopic sphincterotomy procedure (est) performed on (b)(6) 2025.It was reported that during the procedure, it was noted that there was a foreign object in the channel, and the guidewire could not be advanced.Another wallflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: a photograph was provided by the complainant showing that the guidewire access sleeve (gas) ramp was lifted.
Additional Manufacturer Narrative
Block h6: imdrf device code a0180104 captures the reportable event of device - foreign material present in device.Block h11: a wallflex biliary stent with the delivery system was received for analysis.Visual inspection of the returned device found the stent fully covered and undeployed.Functional inspection was performed by backloading a guidewire, and it was observed that the guidewire did not exit at the guidewire access sleeve (gas) ramp.This was expected as the gas ramp was returned lifted.The inner shaft was broken, the outer sheath was stretched, and an internal obstruction was observed.After a destructive test, procedural residue was observed inside the gas section.In addition, media analysis was performed on a provided photograph that showed the gas ramp lifted as well.Product analysis confirmed the reported events of device difficult to advance guidewire, device foreign material present in device and sheath damaged/defective.The investigation concluded that the observed residue is consistent with material introduced during the procedure (i.E.Tissue, blood, or fibers from the procedural environment) during device use.The presence of this residue within the gas section likely caused guidewire blockage and interfered with device functionality.Therefore, the reported events were most likely caused by procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).The most probable cause of the reported events is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary uncovered stent was to be implanted to treat a bile duct tumor during an endoscopic retrograde cholangiopancreatography procedure (ercp), with endoscopic nasobiliary drainage procedure (enbd) and endoscopic sphincterotomy procedure (est) performed on (b)(6) 2025.It was reported that during the procedure, it was noted that there was a foreign object in the channel, and the guidewire could not be advanced.Another wallflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: a photograph was provided by the complainant showing that the guidewire access sleeve (gas) ramp was lifted.

• 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: 22727062
• Report Number: 3005099803-2025-03709
• Device Sequence Number: 8418468
• Product Code: FGE
• UDI-Device Identifier: 08714729756231
• UDI-Public: (01)08714729756231(17)261125(10)35362231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 11/27/2025

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 Model Number: M00570640
• Device Catalogue Number: M00570640
• Device Lot Number: 0035362231
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 56 KG