MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT BILIARY; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	H965430600
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: impact code f05 is being used to capture the reportable event of delay to treatment/therapy.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary uncovered stent was used to treat a cholangiocarcinoma during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was unable to deploy and was fully covered by the outer sheath when it was removed from the patient.The procedure was completed at a later time with another wallstent biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: impact code f05 is being used to capture the reportable event of delay to treatment/therapy.Block h10: a wallstent biliary stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection observed no problems with the device.Functional inspection was performed, the delivery system was actuated (the handle was slide back along the stainless-steel tube), and the stent was able to be deployed without resistance.Product analysis did not confirm the reported event of stent failure to deploy.There is no indication on the reported event because the stent was able to be deployed during functional inspection.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary uncovered stent was used to treat a cholangiocarcinoma during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was unable to deploy and was fully covered by the outer sheath when it was removed from the patient.The procedure was completed at a later time with another wallstent biliary stent.There were no patient complications reported as a result of this event.

• Brand Name: WALLSTENT BILIARY
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17785504
• Report Number: 3005099803-2023-04998
• Device Sequence Number: 15097161
• Product Code: JCT
• UDI-Device Identifier: 08714729204688
• UDI-Public: 08714729204688
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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: 02/20/2025
• Device Model Number: H965430600
• Device Catalogue Number: 3060
• Device Lot Number: 0031091013
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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