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

Model Number	MAJ-1351
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a diagnostic endoscopic bronchial ultrasound (ebus) linear fine needle aspiration (fna), the scope channel was clogged causing an obstruction.The clinician was unable to pass an instrument through the channel and the balloon failed, stating when launching the balloon, it slipped off the scope.The initial pass of the needle was fine, however after several passes, the needle got stuck and would not pass.There was no injury to the patient.While there was a delay, the time is unknown.The intended procedure was not complete.It was aborted and the patient will be rescheduled.The patient was under general anesthesia.

• Brand Name: BALLOON
• Common Device Name: BALLOON
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 19733806
• Report Number: 2429304-2024-0000332
• Device Sequence Number: 7117672
• Product Code: PSV
• UDI-Device Identifier: 04953170360459
• UDI-Public: 04953170360459
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/12/2024
• Report Date (Section F): 06/14/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-1351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/14/2024
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BF-UC190F SCOPE: SN (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown