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

Model Number	M00570530
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was attempted to be implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2026, it was reported that during unpacking outside the patient, the tip of the stent was found bent.Another walflex biliary stent was used to complete the procedure.There were no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of tip damage defective.Block h11: investigation results: boston scientific corporation could not confirm the reported event of tip damaged/defective.The device was not returned; therefore, product analysis could not be performed.Based on the information available there was no evidence to determine whether the reported event was due to physician device manipulation during the procedure or related to a device malfunction, and without proper evaluation of the device, it remains unknown the most probable causes that contributed to the events.Device history record review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which have contributed to the reported event device technical analysis: the device was not returned; therefore, product analysis could not be performed.Risk review: a risk review was completed and confirmed that the event of "tip damaged/defective" was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: 25119167
• Report Number: 3005099803-2026-01677
• Device Sequence Number: 16040924
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: (01)08714729764915(17)270604(10)36671475
• 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
• Report Date (Section B): 05/07/2026

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 Model Number: M00570530
• Device Catalogue Number: M00570530
• Device Lot Number: 0036671475
• 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: 04/08/2026
• Initial Report FDA Received Date: 05/07/2026
• Date Device Manufactured: 06/04/2025
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 73 KG