MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE BALLOON CATHETER

Model Number	B5-2C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The referenced device was not returned for evaluation, therefore, the cause of the reported event cannot be determined.Pneumothorax is a documented potential adverse event associated with the spiration valve system.This reported event has been reported by the importer on mdr# 2951238-2020-00315.
Event or Problem Description
The service center was informed that the device (balloon catheter) was used during a spiration valve procedure.The doctor at the user facility reported the spiration valves were placed in the patient's left lung and approximately 5 minutes after extubation, the patient developed a cough that could not relieved by a nebulizer.A chest x-ray revealed the patient developed a pneumothorax in the left upper lobe.A chest tube was placed to treat the pneumothorax.The procedure was completed, the spiration valves were not removed.The patient was hospitalized for two weeks and then discharged to home.Additionally, the devices were inspected prior to procedure.There was no reported malfunction of the device.

• Brand Name: DISPOSABLE BALLOON CATHETER
• Common Device Name: DISPOSABLE BALLOON CATHETER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9593329
• Report Number: 8010047-2020-00904
• Device Sequence Number: 3461321
• Product Code: EOQ
• UDI-Device Identifier: 04953170047398
• UDI-Public: 04953170047398
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K962901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2020

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: 99K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/15/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 89