MAUDE Adverse Event Report: GYRUS ACMI, INC EZDILATE BALLOON DILATOR (WG) 16-17-18 (JAPAN); EZDILATE 3-STAGE BALLOON DILATATION CATHETER

Model Number	BD-420X-1855
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned for evaluation, as the facility discarded the device.Therefore, the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
It was reported that during an esophageal anastomotic dilation procedure using an ezdilate balloon, the balloon broke.The balloon expansion had reached the target pressure, however, the balloon had then ruptured/burst.The product was replaced and the procedure was completed.According to the doctor, the balloon may have burst in contact with a stapler or the like.The broken balloon was discarded after the procedure.There was no patient injury or harm associated with the issue.
Additional Manufacturer Narrative
This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation.The legal manufacturer performed an investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the issue could not be conclusively specified as the device was not returned.

• Brand Name: EZDILATE BALLOON DILATOR (WG) 16-17-18 (JAPAN)
• Common Device Name: EZDILATE 3-STAGE BALLOON DILATATION CATHETER
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11304104
• Report Number: 3003790304-2021-00029
• Device Sequence Number: 4996934
• Product Code: FGE
• UDI-Device Identifier: 00821925033269
• UDI-Public: 00821925033269
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: BD-420X-1855
• Device Lot Number: 524079V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1