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

Model Number	H965404520
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional number g4.Pma/510(k): k980163.
Event or Problem Description
It was reported that device sizing did not align with the box label.A 22x70/10 wallstent was selected for use.During the procedure, the physician noted that the wallstent sizing did not match the dimensions indicated on the box label and chose to remove the stent instead of deploying it.After removal, the lab deployed the stent on the table to assess its actual size and determined that the sizing did not align with the measurements provided on the box.The procedure was completed and there were no patient complications reported.
Event or Problem Description
It was reported that device sizing did not align with the box label.A 22x70/10 wallstent was selected for use.During the procedure, the physician noted that the wallstent sizing did not match the dimensions indicated on the box label and chose to remove the stent instead of deploying it.After removal, the lab deployed the stent on the table to assess its actual size and determined that the sizing did not align with the measurements provided on the box.The procedure was completed and there were no patient complications reported.It was further reported that the size was determined by measuring through angiography during the case.
Additional Manufacturer Narrative
Additional number g4.Pma/510(k): k980163.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21164052
• Report Number: 2124215-2024-83388
• Device Sequence Number: 13146420
• Product Code: JCT
• UDI-Device Identifier: 08714729204145
• UDI-Public: 08714729204145
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: 03/22/2025
• Device Model Number: H965404520
• Device Catalogue Number: H965404520
• Device Lot Number: 0031288005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/06/2025
• Date Device Manufactured: 03/23/2023
• 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