MAUDE Adverse Event Report: US ENDOSCOPY LUMIFLEX; BALLOON DILATION CATHETER

Model Number	00715518W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, their lumiflex 3-stage balloon dilation catheter was unable to be deflated.The procedure was completed successfully, following a short delay after user facility personnel removed the scope and balloon together and cut the catheter to allow it to be fully extracted from the working channel.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event is being returned to steris for evaluation.Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.

• Brand Name: LUMIFLEX
• Common Device Name: BALLOON DILATION CATHETER
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 24688665
• Report Number: 1528319-2026-00024
• Device Sequence Number: 18605541
• Product Code: KNQ
• UDI-Device Identifier: 00857068006006
• UDI-Public: (01)00857068006006(11)250326(17)280325(10)3732A19250326
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 00715518W
• Device Catalogue Number: 00715518W
• Device Lot Number: (10)3732A19250326
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/25/2026
• Date Device Manufactured: 03/26/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown