MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (WG) 18-19-20; OESOPHAGEAL BALLOON CATHETER

Model Number	BD-410X-2055
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was returned to olympus; however, evaluation has not yet begun.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that an ezdilate balloon dilator burst during a therapeutic dilatation of the bile ducts.No parts came loose from the balloon.The procedure was prolonged for an unspecified duration with no impact to the patient and was completed using another balloon.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to correct b5.The information in b5 was inadvertently left off from the initial mdr.
Event or Problem Description
Two balloons had failed during the procedure; one balloon burst, and the other balloon failed to deploy.The procedure was completed with a third balloon.The initial mdr was submitted for the reportable malfunction and serious injury from the burst balloon.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide a correction to the initial (updated fields h3 and h4).The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The complete evaluation results are as followed: towards the distal end of the device, the balloon was found to be missing.The remaining piece of the balloon had traces of a red foreign material and seemed to be cut off.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, it is likely that the suggested event occurred due to the seam connecting the two halves of the balloon is not correct.However, the root cause of the suggested event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EZDILATE BALLOON DILATOR (WG) 18-19-20
• Common Device Name: OESOPHAGEAL BALLOON CATHETER
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17572505
• Report Number: 3003790304-2023-00326
• Device Sequence Number: 8886472
• Product Code: FGE
• UDI-Device Identifier: 00821925033276
• UDI-Public: 00821925033276
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2024

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: BD-410X-2055
• Device Lot Number: 374101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 10/17/2023; 01/11/2024
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 10/18/2023; 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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: THIRD-PARTY ENDOSCOPE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown