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

Model Number	BD-410X-1855
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been returned for evaluation/investigation.Therefore, the root cause of the reported phenomenon could not be determined at this time.This report will be supplemented accordingly following investigations.
Event or Problem Description
It was reported that during an endoscopic retrograde cholangiopancreatography (ercp) bile duct dilatation for stone extraction the balloon catheter burts between procedure when it was already inflated.The intended procedure was completed with other company device.There was no patient injury reported, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A physical evaluation cannot be completed at this time as the device has not been returned.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Olympus will continue to monitor complaints for this device.

• Brand Name: EZDILATE BALLOON DILATOR (WG) 16-17-18
• Common Device Name: EZDILATE BALLOON DILATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11929381
• Report Number: 3003790304-2021-00101
• Device Sequence Number: 14293540
• Product Code: KNQ
• UDI-Device Identifier: 00821925033269
• UDI-Public: 00821925033269
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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-410X-1855
• Device Lot Number: 512089D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1