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

Model Number	B5-2C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pneumothorax (2012); Respiratory Failure (2484)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "off-label use of intrabronchial valves for persistent air leak is safe and effective: a retrospective case analysis".Persistent air leak (pal) is a challenging clinical problem associated with prolonged hospital stay and increased morbidity.Historically, treatment options were limited to thoracostomy tube drainage, pleurodesis, and surgical repair.The development of one-way airway valves has represented a paradigm shift in pal management.We present our experience using intrabronchial valves (ibvs) for pal management looking at both on-label (post-thoracic surgery) and off-label (all other) indications.During the study period, 15 patients underwent ibv insertion for pal.The on-label cohort contained three patients (post lobectomy or segmentectomy).The off-label cohort had 12 patients.(6 empyema, 4 secondary spontaneous pneumothorax, 1 penetrating trauma, and 1 post percutaneous lung nodule biopsy).In the on-label cohort, chest tube was removed after a mean duration of 4.0±1.0 days for all patients.In the off-label cohort, 83.3% (10/12) had chest tube removal 16.2±5.7 days (p=0.396) after ibv placement.One patient developed hypoxic respiratory failure shortly after ibv insertion, necessitating removal of 2 out of 5 valves.Type of adverse events/number of patients.Immediate respiratory failure.Off-label cohort: empyema 6 patients; secondary spontaneous pneumothorax 4 patients; penetrating trauma 1 patient ; post percutaneous lung nodule biopsy 1 patient.On-label cohort: one patient developed hypoxic respiratory failure shortly after ibv insertion, necessitating removal of 2 out of 5 valves.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) / bf-1th190.(b)(6) / b5-2c.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

• Brand Name: DISPOSABLE BALLOON CATHETER
• Common Device Name: DISPOSABLE BALLOON CATHETER
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 16555337
• Report Number: 2429304-2023-00045
• Device Sequence Number: 4948224
• Product Code: EOQ
• UDI-Device Identifier: 04953170047398
• UDI-Public: 04953170047398
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2023
• Report Date (Section F): 02/27/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: B5-2C
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2023
• 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