MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WallFlex? Biliary; catheter, biliary, diagnostic

Model Number	M00570530
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx covered stent was implanted in the biliary tract to treat a biliary stenosis during a stent placement procedure performed on (b)(6) 2026.Post procedure, it was noted that the stent was dislodged.The device was removed, and a different device was used to complete the procedure.There were no patient complications as a result of this event and the patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter's facility name is la(b)(6) hospital; reported here as facility name exceeded character limit for designated field.Initial reporter address: (b)(6) ; reported here as facility name exceeded character limit for designated field.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the reportable event of the additional device required to remove the mispositioned stent.

• 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 ; +1(914)571-6918
• MDR Report Key: 50047758
• Report Number: 3005099803-2026-03052
• Device Sequence Number: 18798721
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: (01)08714729764915(17)270909(10)37409410
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/09/2026

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: M00570530
• Device Catalogue Number: M00570530
• Device Lot Number: 0037409410
• 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: 07/03/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 09/09/2025
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 127 LB