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

Model Number	H965404130
Medical Device Problem Codes	Unsealed Device Packaging (1444); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner package leaked air.The stenosed target lesionw as located in the common bile duct.A 18x90 wallstent self expanding was selected for use.During preparation, upon opening the package, it was observed that the inner packaging had an air leak, resulting in a compromise of the device's sterility.The procedure was completed using with another of the same device.There wee no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: only the device was returned, no carton or inner pouch returned with device.The stent was returned unsheathed on the device.A visual and tactile examination identified multiple outer sheath kinks.A visual and tactile examination identified no issues with the tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the inner package leaked air.The stenosed target lesion was located in the common bile duct.A 18x90 wallstent self-expanding was selected for use.During preparation, upon opening the package, it was observed that the inner packaging had an air leak, resulting in a compromise of the device's sterility.The procedure was completed using with another of the same device.There were no patient complications as a result of this event.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21552566
• Report Number: 2124215-2025-12802
• Device Sequence Number: 4402275
• Product Code: JCT
• UDI-Device Identifier: 08714729204084
• UDI-Public: (01)08714729204084(17)250301(10)31152071
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• 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,Followup
• Report Date (Section B): 04/28/2025

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: 03/01/2025
• Device Model Number: H965404130
• Device Catalogue Number: H965404130
• Device Lot Number: 0031152071
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 86 KG