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

Model Number	H965431200
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of a cancelled/rescheduled procedure.
Event or Problem Description
It was reported to boston scientific corporation that an endoscopic covered biliary stent was used to treat a malignant biliary stricture in the bile duct during a biliary metal stenting procedure performed on (b)(6) 2025.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent failed to deploy.Consequently, the procedure was cancelled.There were no patient complications reported as a result of this event.

• Brand Name: WALLSTENT? 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: 22935815
• Report Number: 3005099803-2025-04409
• Device Sequence Number: 21312237
• Product Code: FGE
• UDI-Device Identifier: 08714729229902
• UDI-Public: (01)08714729229902(17)251219(10)33097431
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K000308
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2025

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: 12/19/2025
• Device Model Number: H965431200
• Device Catalogue Number: H965431200
• Device Lot Number: 0033097431
• 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: 08/07/2025
• Initial Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 12/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown