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

Model Number	M00570730
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted in the bile duct for drainage and treatment of an obstruction during a stent implantation procedure performed on (b)(6) 2025.During the procedure, the stent was dislocated after release.The procedure was completed with another of the same device.No patient complications were reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Blocks b5 and h6 have been corrected.Block e1 initial reporter's address has been updated based on the additional information received on june 23, 2025.Block h11: a wallflex biliary stent and delivery system were received for analysis.Visual inspection of the returned device found the stent was fully deployed and expanded.The outer blue sheath was found kinked.No other damage was noted to the stent and delivery system.Product analysis did not confirm the reported event of stent partially deployed as the stent was returned fully deployed and expanded.The investigation concluded that the additional observed event of sheath kinked was most likely due to procedural factors such as excess of force or the manner as the device was handled and manipulated.There is insufficient information to determine the root cause of the reported failure.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx partially covered stent was to be implanted in the bile duct for drainage and treatment of an obstruction during a stent implantation procedure performed on (b)(6) 2025 during the procedure, the stent was not fully deployed.The device was removed from the patient partially deployed on the delivery system.The procedure was completed with another of the same device.No patient complications were reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 22290651
• Report Number: 3005099803-2025-02682
• Device Sequence Number: 12841842
• Product Code: FGE
• UDI-Device Identifier: 08714729759324
• UDI-Public: (01)08714729759324(17)270123(10)35700180
• 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): 07/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00570730
• Device Catalogue Number: M00570730
• Device Lot Number: 0035700180
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 70 KG