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
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2025-00099.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
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
It was reported that stents were placed in the patient and hemoclips were used to close perforation.
Additional Manufacturer Narrative
Additional information was provided by the customer that stents were placed and hemoclips were use to closed the perforation.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received from the customer and based on the approved final investigation as well as to correct b5 of the previous supplemental report.Upon further review, a stent was placed in the patient, not stents.Updated fields: b5, b7, h6, h11.The device was not returned to olympus for inspection.The manufacturing date was november 2023.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.It was discussed that a likely factor causing perforation might be the following: 1.The distal end of the insertion portion was forcefully pushed against the body tissue.2.The condition of the patient¿s tissue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the patient currently has no issues and was seen in office with no complaints.

• 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
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21579517
• Report Number: 9614641-2025-00297
• Device Sequence Number: 9217407
• Product Code: KNS
• UDI-Device Identifier: 04953170414084
• UDI-Public: 04953170414084
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K193039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 10/30/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/17/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown