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

Model Number	H965430600
Medical Device Problem Codes	Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary stent was to be implanted in the common bile duct to treat a malignant stricture during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, it was noted that the stent wire was popping out of the sheath and seemed to be broken.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event.Note: a photo of the device was provided by the complainant, and it was noted that the stent wire punctured the outer sheath.
Additional Manufacturer Narrative
Block d2b: product code esw, fge, jct, mqr, mum - reported here as the product code exceeded the maximum character limit for the designated field.Block h6: imdrf device code a041001 captures the reportable event of stent wire punctured sheath.
Additional Manufacturer Narrative
Block d2b: product code esw, fge, jct, mqr, mum - reported here as the product code exceeded the maximum character limit for the designated field.Block h6: imdrf device code a041001 captures the reportable event of stent wire punctured sheath.Block h11: a wallstent biliary stent with its delivery system was returned for analysis.Visual examination of the returned device found the outer sheath kinked and the sheath punctured by the stent wire.Media inspection was performed on a provided photograph, and it was observed again that the sheath was punctured by the stent wire.No other problems were noted to the delivery system.Product analysis confirmed the reported event of stent wire punctured sheath as it was observed that the sheath was punctured by the stent wire during visual analysis of the returned device.However, the investigation concluded that there is not enough evidence to determine if the reported event was due to the physician's device manipulation during the procedure, related to device malfunction, or due to external factors such as transport and storage.Boston scientific includes intensive inspections and procedures to ensure that all devices meet the manufacturing conditions and specifications, including visual confirmation and seal inspection to ensure their integrity.On the other hand, the additional observed damage of outer sheath kinked was most likely caused due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Therefore, taking all available information into consideration, cause not established is selected as the most probable root cause.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary stent was to be implanted in the common bile duct to treat a malignant stricture during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, it was noted that the stent wire was popping out of the sheath and seemed to be broken.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event.Note: a photo of the device was provided by the complainant, and it was noted that the stent wire punctured the outer sheath.

• 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: 20920570
• Report Number: 3005099803-2024-06268
• Device Sequence Number: 12833463
• Product Code: ESW
• UDI-Device Identifier: 08714729204688
• UDI-Public: (01)08714729204688(17)251112(10)32838089
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: 11/12/2025
• Device Model Number: H965430600
• Device Catalogue Number: H965430600
• Device Lot Number: 0032838089
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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