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

Model Number BD-410X-2055

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that in the middle of a therapeutic esophageal dilation procedure two balloon devices burst.There was a delay approximately 3 to 5 minutes while the patient was under n-acetylcysteine (nac) anesthesia.The procedure was completed with balloon and syringe from a different lot (lot number unknown).No pieces of the balloon fell into the patient.The devices were inspected prior to use with no abnormalities found.The balloons were not lubricated.The balloons were not tied in a knot nor was string used to tie off the balloon end.The dilator was not used with a test balloon.There were no resistance noted during insertion, or withdrawal of the balloon.There was no patient harm, or injury reported due to the event.No user injury reported.This report is related to report patient identifier: (b)(4).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A physical evaluation cannot be completed as the device was not returned and the customer did not provide any pictures of the device.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) 18-19-20
• Type of Device: EZDILATE BALLOON DILATOR (WG) 18-19-20
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10994981
• MDR Text Key: 221275858
• Report Number: 3003790304-2020-00139
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K143609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD-410X-2055
• Device Lot Number: 520040C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYRINGES.