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

Model Number	M00570530
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: imdrf device code a0401 captures the investigation findings of stent retrieval loop broken.H11: the wallflex biliary stent and its delivery system was returned for analysis.Visual examination of the returned device revealed that the stent was deployed, and the clear outer sheath was kinked.In addition, the stent retrieval loop was broken.No other problems were noted with the stent and the delivery system.Product analysis could not confirm the reported event of stent partially deployed as the returned stent was found deployed.The investigation concluded that the observed damages of stent retrieval loop broken, and clear outer sheath kinked were most likely due to procedural factors encountered during the procedure.It may be that tortuosity of the procedure, and the manipulation or technique used by the physician, limited the performance of the device and contributed to the observed damages.Due to the lack of objective evidence supporting the reported event, the review and analysis of all available information concluded that the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted in the biliary tract to treat a malignant tumor during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the stent could not be fully deployed.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Note: this event has been deemed a reportable event based on the investigation finding of stent retrieval loop was broken.Please see block h11 for full investigation details.

• 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: 22715080
• Report Number: 3005099803-2025-03806
• Device Sequence Number: 9924141
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: (01)08714729764915(17)260109(10)33182343
• 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): 08/05/2025

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: 01/09/2026
• Device Model Number: M00570530
• Device Catalogue Number: M00570530
• Device Lot Number: 0033182343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 66 KG