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

Model Number	M00570600
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a150103 captures the reportable event of stent premature deployment.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was used to treat a bile duct cancer during a biliary stent implantation procedure performed on (b)(6) 2025.During the procedure, when the device was taken out from the outer package after it was opened, the spring automatically jumped out.The procedure was completed with another device of the same type.There were no patient complications reported as a result of this event, and the patient's condition remained stable following the procedure.
Additional Manufacturer Narrative
Block a1: patient's identifier has been updated with the additional information received on march 17, 2025.Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was used to treat a bile duct cancer during a biliary stent implantation procedure performed on (b)(6) 2025.During the procedure, when the device was taken out from the outer package after it was opened, the spring automatically jumped out.The procedure was completed with another device of the same type.There were no patient complications reported as a result of this event, and the patient's condition remained stable following the procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was used to treat a bile duct cancer during a biliary stent implantation procedure performed on (b)(6) 2025.During the procedure, when the device was taken out from the outer package after it was opened, the spring automatically jumped out.The procedure was completed with another device of the same type.There were no patient complications reported as a result of this event, and the patient's condition remained stable following the procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.Block h11: a wallflex biliary delivery system was received for analysis; the stent was not returned.Visual examination of the returned device did not find any damages to the delivery system.Product analysis did not confirm the reported event of stent premature deployment as this event occurred during the procedure, and it is not possible to replicate in the laboratory of analysis.Taking all available information into consideration, investigation findings do not lead to a clear conclusion about the cause of the reported event.Therefore, a review and analysis of all available information indicated the most probable cause is 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21628038
• Report Number: 3005099803-2025-01027
• Device Sequence Number: 8938901
• Product Code: FGE
• UDI-Device Identifier: 08714729759249
• UDI-Public: (01)08714729759249(17)260301(10)33537708
• 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,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: 03/01/2026
• Device Model Number: M00570600
• Device Catalogue Number: M00570600
• Device Lot Number: 0033537708
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 03/17/2025; 04/15/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/10/2025; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 55 KG