MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE BALLOON CATHETER

Model Number	B5-2C
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The olympus representative reported on behalf of the customer, at the beginning of the therapeutic procedure for a prolonged air leak, the user blew up the disposable balloon catheter past its capacity trying to fill the entire airway, and it popped causing a five minute delay.The user was able to quickly remove the popped balloon with forceps, and the airway was visually inspected and it was confirmed there was no balloon debris left in the airway and no further intervention was necessary.Three 9mm spiration valves were placed in the patient successfully.The procedure was completed successfully with a new balloon catheter and there was no reported patient harm.

• Brand Name: DISPOSABLE BALLOON CATHETER
• Common Device Name: DISPOSABLE BALLOON CATHETER
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonok; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 18264074
• Report Number: 2429304-2023-00378
• Device Sequence Number: 20805833
• Product Code: EOQ
• UDI-Device Identifier: 04953170047398
• UDI-Public: 04953170047398
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2023
• Report Date (Section F): 11/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: B5-2C
• Device Lot Number: 28K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/06/2023
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown