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

Model Number	H965430500
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary uncovered stent was used to treat a malignant biliary obstruction during a stent placement procedure performed on (b)(6) 2023.During the procedure, the guidewire was loaded and stent deployment was attempted; however, the stent failed to deploy.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.Note: photos of the complaint device were provided showing the stent wires from the partially deployed stent.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary uncovered stent was used to treat a malignant biliary obstruction during a stent placement procedure performed on (b)(6) 2023.During the procedure, the guidewire was loaded and stent deployment was attempted; however, the stent failed to deploy.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.Note: photos of the complaint device were provided showing the stent wires from the partially deployed stent.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b1 and block g1 (manufacturer contact person) have been updated.Block h8 has been corrected.Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h11: a wallstent biliary stent with its delivery system was returned for analysis.Visual examination of the returned device found the stent partially deployed, wallstent cap detached, and the inner sheath was out of the stainless steel.Media inspection was performed on a provided photograph, and stent wires from the partially deployed stent was observed.No other problems were noted to the delivery system.Product analysis confirmed the reported event of stent partially deployed as it was observed during visual analysis of the returned device.In addition, the wallstent cap was detached, and the inner sheath was out of the stainless steel.The investigation concluded that the reported event was most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician.Based on all available information, the selected most probable root cause was adverse event related to procedure.

• 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: 17939255
• Report Number: 3005099803-2023-05524
• Device Sequence Number: 12461170
• Product Code: JCT
• UDI-Device Identifier: 08714729204671
• UDI-Public: 08714729204671
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K982184
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 09/18/2024
• Device Model Number: H965430500
• Device Catalogue Number: H965430500
• Device Lot Number: 0030170758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male