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
Additional Manufacturer Narrative
Since the literature described "balloon occlusion using a 13-mm balloon", olympus selected "b5-2c" as a representative product.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under this mdr report number 2429304-2023-00045.
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.
Event or Problem Description
This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6).This medwatch report is for patient identifier (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, additional information to b5 and d10.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• 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
• 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: 16555529
• Report Number: 9614641-2023-00383
• Device Sequence Number: 12093914
• Product Code: EOQ
• UDI-Device Identifier: 04953170047398
• UDI-Public: 04953170047398
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K962901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 05/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BF-1TH190; SPIRATION® VALVE SYSTEM (SVS)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown