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

Model Number	M0062251020
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a uromax ultra dilation balloon catheter was used during a ureterorenolithotripsy (ursl) procedure.During the procedure, it was found that the coil of the tail was broken.The procedure was completed with another of the same device with no patient complications.
Event or Problem Description
It was reported that a uromax ultra dilation balloon catheter was used during a ureterorenolithotripsy (ursl) procedure.During the procedure, it was found that the coil of the tail was broken and the balloon could not be inflated.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Blocks d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0401 captures the reportable event of catheter break.
Additional Manufacturer Narrative
Blocks d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h2: additional information: block b5 (describe event or problem) and block h6 (device code) have been updated to capture that this event will no longer be reportable.

• 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, ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50196975
• Report Number: 2124215-2026-42677
• Device Sequence Number: 10274290
• Product Code: EZN
• UDI-Device Identifier: 08714729341123
• 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,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: M0062251020
• Device Catalogue Number: 225-102
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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