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

Model Number	B5-2C
Health Effect - Clinical Codes	Pneumothorax (2012); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported during aspiration valve procedure for bronchoscopic lung volume reduction (indication: emphysema) using a disposable balloon catheter, the distal tip of catheter was noticeably bent when in view through working channel of scope.The bend did not allow proper navigation in left upper lobe for accurate sizing.Balloon was taken out and replaced with a new one.The patient experienced almost immediate atelectasis of the left upper lobe and pneumothorax.The patient was taken to interventional radiology (ir) for chest tube placement, and then to the intensive care unit (icu).There were no reported challenges with the patient's anatomy that could have caused or contributed to the reported event.The patient's current condition is reported to be good with improvement in his breathing at home with daily exercises.
Event or Problem Description
Correction to g3 of the initial medwatch.The aware date should be 19-may-2021.

• 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: 11999861
• Report Number: 2951238-2021-00347
• Device Sequence Number: 14252237
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022
• Report Date (Section F): 05/19/2021

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: 14K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 12/07/2022
• 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; Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 95 KG