MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (FW) 6-7-8

Model Number	BD-400P-0880
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The device was not returned to olympus for evaluation, therefore the complaint could not be confirmed.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, balloon bursts may be caused by over inflating the balloon.This may be due to using improper inflation device or customer error.The balloon may be damaged during insertion either through scrapping or gouging when passing through the endoscope or on staples, if present, in the patient¿s intestine.This may cause it to burst during inflation.All balloon catheters are 100% leak tested during the manufacturing process.Any leaking balloons are scrapped.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
Olympus was notified of an out of box failure for one bd-400p-0880 balloon.While the balloon was inside the patient, the customer inflated the balloon to 6mm and the balloon ruptured inside the patient.The ruptured balloon was retrieved from inside the patient and the procedure was able to be completed successfully with a second bd-400p-0880.There was no harm or user injury reported due to the event.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 6-7-8
• Common Device Name: BALLOON DILATOR
• Manufacturer (Section D): 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: 15311229
• Report Number: 3003790304-2022-00176
• Device Sequence Number: 5467024
• Product Code: PNZ
• UDI-Device Identifier: 00821925033160
• UDI-Public: 00821925033160
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT-KNQ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2022

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-0880
• Device Lot Number: 513040D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• 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
• Patient Sex: Unknown