MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE BALLOON DILATOR V (WITH KNIFE)

Model Number	BD-VC431Q-1240-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while the patient was under sedation for a therapeutic endoscopic retrograde cholangiopancreatography, the user was using the cutting wire to cut the papilla and the cutting wire perforated the patient's bile duct.The procedure ended once the perforation occurred and the patient was taken to another room to address the perforation.
Event or Problem Description
This report is being supplemented to provide additional information received from the customer indicating that a stent was placed and hemoclips were used to close the perforation.The patient currently has no issues and was seen in office with no complaints.Updated fields: b2, b5, b7, f9, f10.

• Brand Name: SINGLE USE BALLOON DILATOR V (WITH KNIFE)
• Common Device Name: BALLOON DILATOR
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 21579946
• Report Number: 2429304-2025-00099
• Device Sequence Number: 8757594
• Product Code: KNS
• UDI-Device Identifier: 04953170414084
• UDI-Public: 04953170414084
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025
• Report Date (Section F): 11/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BD-VC431Q-1240-20
• Device Lot Number: 3YK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/30/2025
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 11/03/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/03/2025