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

Model Number	BD-VC431Q-1240-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a sample product of a balloon dilator with knife was used during a bile duct stone removal procedure.The procedure was completed without any issues.An unknown amount of time later, the patient suffered a bile duct perforation and emergency surgery was performed.The cause was unknown.There was no reported serious problems for the patient.According to the surgeon, it was unlikely that the balloon caused the perforation as it was inflated at a low pressure, but it was not clear what role the device may have contributed.
Additional Manufacturer Narrative
The device was disposed of and will not be returned.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out (d4 and g2).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, the root cause of the reported event could not be identified, with the information received.The event can be prevented, by following the instructions for use.Which state: "when applying the current, do not use an excessive/insufficient amount of conduction.This could cause patient injury such as perforations and/or bleeding.When necessary, provide treatments to prevent perforations or bleeding from occurring.Ensure that postoperative follow-ups are performed.And confirm, that no irregularities are found in the patient".Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19014244
• Report Number: 9614641-2024-00807
• Device Sequence Number: 3875493
• Product Code: KNS
• UDI-Device Identifier: 04953170414107
• UDI-Public: 04953170414107
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

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-1240-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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