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

Model Number BD-VC431Q-1240-25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Date 02/27/2024

Event Type  Injury  

Event 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.

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.

• Brand Name: SINGLE USE BALLOON DILATOR V (WITH KNIFE)
• Type of Device: 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: 19014244
• MDR Text Key: 339048039
• Report Number: 9614641-2024-00807
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2024

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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention