MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (WG) 11-12-13; OESOPHAGEAL BALLOON CATHETER

Model Number	BD-410X-1355
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the balloon burst.The reported problem was found during a therapeutic esophageal dilation which was completed successfully.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation where service confirmed the customer's complaint.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root cause was unable to be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information was provided.The intended procedure was delayed and the patient's anesthesia or sedation was extended not more than five minutes, to allow the user to pull another balloon.The condition of the patient was not impacted by the event and no medical intervention was required.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received from the customer.Correction to h10: it is likely the balloon burst due to reinflation.The instructions for use (ifu) warns: "caution: do not pre-test balloon by inflating before insertion into the endoscope, any attempt to refold the balloon may result in compromised performance, or failure of the device." the investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

• Brand Name: EZDILATE BALLOON DILATOR (WG) 11-12-13
• Common Device Name: OESOPHAGEAL BALLOON CATHETER
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17092013
• Report Number: 3011050570-2023-00060
• Device Sequence Number: 17659941
• Product Code: KNQ
• UDI-Device Identifier: 00821925033245
• UDI-Public: 00821925033245
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2023

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 Expiration Date: 12/04/2025
• Device Model Number: BD-410X-1355
• Device Lot Number: 370496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 07/26/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/05/2023; 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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: EZDILATE INFLATION DEVICE (MAJ-1740)
• Patient Sex: Unknown