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

Model Number	M0062251290
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0402 captures the reportable event of balloon burst.
Event or Problem Description
It was reported that a uromax ultra dilation balloon catheter was used during a dilation of ureter procedure.During the procedure, the balloon burst.The procedure was completed with another of the same device with no patient complications.

• Brand Name: UroMax Ultra Kit
• 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 ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25725454
• Report Number: 2124215-2026-36068
• Device Sequence Number: 5777931
• Product Code: EZN
• UDI-Device Identifier: 08714729341369
• UDI-Public: (01)08714729341369(17)261210(10)33354983
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup,Followup
• Report Date (Section B): 10/01/2026

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: M0062251290
• Device Catalogue Number: M0062251290
• Device Lot Number: 0033354983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 07/15/2026; 09/09/2026
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 08/06/2026; 10/01/2026
• Date Device Manufactured: 12/11/2023
• 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 Age: 51 YR
• Patient Sex: Male
• Patient Weight: 178 LB