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

Model Number	B7-2Q
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use recommend inflation to 2.33cc maximum and the doctor inflated to 9cc; the device was overinflated by 6.7cc, likely causing it to pop.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The respiratory manager at the user facility informed olympus that during an air leak procedure, the disposable balloon catheter reportedly popped and a piece went into the patient.Surgeon was able to retrieve the piece with no patient injury or harm.The doctor inflated to 9cc.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional information from the customer.The user facility further reported that the olympus sales representative ensured that the surgeon did not overinflate as the surgeon also used a smaller syringe to inflate.The olympus sales representative went over the instructions for use with the surgeon.The investigation is ongoing; however, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
There was no clinically significant delays in procedure.The intended procedure was completed using another device.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: g3, g6, h2, h6 and h10.Since the device lot number was unknown, the dhr for the one year prior to the date of occurrence was inspected.No abnormalities detected in the dhr for the following items which related to the reported phenomenon.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on the reported information, excessive force applied to the balloon during inflation likely contributed to the balloon rupture.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: - the volume of the air in the balloon should not exceed the parameters specified in the tables in section 2.2, ¿specifications¿.Otherwise, the balloon may burst or may not deflate properly.When the balloon does not deflate, do not operate the balloon catheter with excessive force.Otherwise, the distal end of the instrument may break off and could remain inside the patient.- do not inflate the balloon rapidly.The balloon may burst and mucous membrane damage can result.Olympus will continue to monitor complaints for this 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: 11522373
• Report Number: 8010047-2021-03948
• Device Sequence Number: 5169927
• Product Code: FGE
• UDI-Device Identifier: 04953170047442
• UDI-Public: 04953170047442
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K962925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: B7-2Q
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 04/06/2021; 04/23/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/06/2021; 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1