MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (FW) 16-17-18

Model Number	BD-400P-1880
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during dilation procedure , the 16-17-18mm (bd-400p-1880) dilatation balloon broke.According to the report, the nurse used olympus inflation handle as instructed in ifu, the balloon filled with out a problem to 16mm and 17mm.When starting to fill to 18mm the balloon suddenly broke inside the patients esophagus.A new 16-17-18mm balloon was then used to perform the dilation procedure without any problem.No excess force had been needed when inserting the balloon through the scope.No rifts or tares were visible when inspected before use.Olympus single use inflation device for ezdilate was used (egmaj-1740) when procedure was performed.No harm was reported.No patient harm, no user injury reported as the result of the event.
Additional Manufacturer Narrative
The subject device was received at olympus business center sweden on jan.27, 2023 and is being shipped to original equipment manufacturer for evaluation.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
The customer provided additional information which confirmed the intended procedure was dilatation of the neck anastomosis after surgery for esophageal cancer.It was reported that the dilation went well.Additionally, the balloon was changed and that went well.When the balloon broke, the procedure was extended, but there was no injury to the patient.The balloon could be pulled out through the instrument after it ruptured, so no other type of equipment was needed to retrieve it.The customer used the same ezdilate egmaj-1740 throughout the procedure with no problems, only this one balloon broke.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and the device evaluation.D10: ezdilate bd-400p-1080 lot no:341807.Ezdilate bd-400p-1380 lot no:343329.Cook 12-13.5-15mm.Cook 18-19-20mm.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The balloon sheath had a minor kink.The luer did not appear to have any damage.The balloon was inspected and there was a confirmed burst.The balloon was ripped open.The device was unable to be function tested as the balloon was damaged.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¿s likely the balloon became damaged during insertion either through scrapping or gouging when passing through the endoscope or on staples in the patient¿s intestine.However, the final root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 16-17-18
• Common Device Name: BALLOON DILATOR
• 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: 16358499
• Report Number: 3003790304-2023-00064
• Device Sequence Number: 20400789
• Product Code: KNQ
• UDI-Device Identifier: 00821925033207
• UDI-Public: 00821925033207
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT-KNQ
• 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
• Report Date (Section B): 05/03/2023

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 Model Number: BD-400P-1880
• Device Lot Number: 365825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/15/2023
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2022
• 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: BD-400P-1080 LOT#:341807, BD-400P-1380 LOT#:343329; EGMAJ-1740INFLATION DEVICE
• Patient Sex: Unknown