MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UroMax Ultra; dilator, catheter, ureteral

Model Number	M0062251000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a uromax ultra dilation balloon catheter was used during a ureteroscopy (urs) procedure.During the procedure, it was found that the coil of the tail was broken.Additionally, when the balloon was being inflated, a leak was discovered that prevented it from fully expanding.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code (b)(4) captures the reportable event of balloon leak.

• Brand Name: UroMax Ultra
• Common Device Name: dilator, catheter, ureteral
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; ballybrit business park; galway H91 Y 868; EI H91 Y868
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50335394
• Report Number: 2124215-2026-44805
• Device Sequence Number: 5750712
• Product Code: EZN
• UDI-Device Identifier: 08714729341109
• UDI-Public: (01)08714729341109(17)261123(10)32922289
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K130804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2026

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: M0062251000
• Device Catalogue Number: M0062251000
• Device Lot Number: 0032922289
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown