MAUDE Adverse Event Report: GYRUS ACMI, INC. GYRUS ACMI, INC; DILATOR, ESOPHAGEAL

Model Number	BD-410X-1855
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Dilation balloon catheter snapped inside of the scope while pulling the catheter out of the scope.

• Brand Name: GYRUS ACMI, INC
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana ave north; brooklyn park MN 55445
• MDR Report Key: 18920749
• Report Number: 18920749
• Device Sequence Number: 14999707
• Product Code: KNQ
• UDI-Device Identifier: 00821925033269
• UDI-Public: (01)00821925033269(17)260611(10)389462
• 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): 01/03/2024
• Report Date (Section F): 01/03/2024

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 Catalogue Number: BD-410X-1855
• Device Lot Number: 389462
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2024
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Date Report Sent to FDA: 01/03/2024