MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE - FIXED WIRE ESOPHAGEAL 3-STAGE BALLOON DILATATION CATHETER; DILATOR, ESOPHAGEAL

Model Number	BD-400P-1080
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Dilation balloon ruptured while in patient.Balloon was being inflated past 7 atmospheres for a 9.5mm diameter when it happened.

• Brand Name: EZDILATE - FIXED WIRE ESOPHAGEAL 3-STAGE BALLOON DILATATION CATHETER
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• MDR Report Key: 18562919
• Report Number: 18562919
• Device Sequence Number: 15168081
• Product Code: KNQ
• UDI-Device Identifier: 00821925033177
• UDI-Public: (01)00821925033177(17)250427(10)346231
• 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-400P-1080
• Device Lot Number: 346231
• 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: Male
• Patient Weight: 74 KG
• Date Report Sent to FDA: 10/03/2023