MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT? BILIARY; PROSTHESIS, ESOPHAGEAL

Model Number	H965430600
Medical Device Problem Codes	Nonstandard Device (1420); Material Puncture/Hole (1504); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation result of inner sheath detached.Imdrf device code a041001 captures the reportable investigation result of stent wire punctured sheath.Block h11: a wallstent biliary uncovered stent and its delivery system were received for analysis.Visual inspection showed that the stainless-steel tube and inner sheath were detached, and both the blue outer sheath and the clear outer sheath were kinked.Microscopic examination further revealed that the stent wire had punctured the clear outer sheath.No other damages were noted to the stent and delivery system.The investigation concluded that the noted damages were most likely due to procedural factors, such as, lesion characteristics, device handling, and the technique used by the physician, including the amount of force applied which could have contributed to the damage noted on the device.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary uncovered stent was to be implanted in the common bile duct to treat a malignant stricture secondary to cholangitis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the stainless-steel tube detached while the physician attempted to deploy the stent.The stent was removed from the patient fully covered by the outer sheath.The procedure was completed using another of the same device.There was no patient complications reported as a result of this event.Note: this complaint has been deemed mdr-reportable based on investigation findings indicating that the inner sheath was detached and the stent wire punctured the clear outer sheath.Please see block h11 for full investigation details.

• Brand Name: WALLSTENT? BILIARY
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• 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 ; 9145716918
• MDR Report Key: 24907115
• Report Number: 3005099803-2026-01409
• Device Sequence Number: 9828001
• Product Code: FGE
• UDI-Device Identifier: 08714729204688
• UDI-Public: (01)08714729204688(17)251205(10)32995675
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: 12/05/2025
• Device Model Number: H965430600
• Device Catalogue Number: H965430600
• Device Lot Number: 0032995675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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 Sex: Unknown