MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE - WIRE GUIDED ESOPHAGEAL/PYLORIC/COLONIC/BILIARY 3-STAGE BAL; DILATOR, ESOPHAGEAL

Model Number	BD-410X-2055
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Balloon dilation of two places in patient's esophagus, after the second time the balloon after deflation would not come back through the scope.Upon removing scope with balloon still through it, it was noticed that the wire had gotten a kink in it at the end which would not allow it to withdrawal through the scope.Wirecutters had to be used to removed the bent part of the wire and remove the balloon from the scope.

• Brand Name: EZDILATE - WIRE GUIDED ESOPHAGEAL/PYLORIC/COLONIC/BILIARY 3-STAGE BAL
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• MDR Report Key: 18562957
• Report Number: 18562957
• Device Sequence Number: 6595202
• Product Code: KNQ
• UDI-Device Identifier: 00821925033276
• UDI-Public: (01)00821925033276(17)260702(10)391512
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2023
• Report Date (Section F): 10/03/2023

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-410X-2055
• Device Lot Number: 391512
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 52 KG
• Date Report Sent to FDA: 10/03/2023