MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UROMAX ULTRA; DILATOR, CATHETER, URETERAL

Model Number	M0062251020
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
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 device was used during a retrograde intrarenal surgery (rirs) procedure.Reportedly, the uromax balloon broke during inflation.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h2: additional information: block b5 (describe event or problem), block e1 (initial reporter address).Block h6: device code a0402 captures the reportable event of balloon burst.Block h11: investigation result the returned uromax ultra balloon device was analyzed, and a visual evaluation noted that the balloon was not folded which indicates that the balloon was subjected to positive pressure.It was also noted that during a leak test, that the balloon was inflated to its rated burst pressure for 30 seconds using deionized water without a problem.A vacuum was then applied, and inflation device was verified at 20 atmospheres before and after use with calibrated pressure gauge.The balloon was inflated and deflated to rate burst pressure three times repeatedly with no leaks or drop in pressure noted.No problem was noted with the balloon inflation or the balloon material.A visual and tactile analysis revealed that there were no problems found to the shaft, and the tip of the device.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.With all the available information, boston scientific concludes that the reported event was not confirmed.Based on the successful inflation of the balloon to rated burst pressure and no device damage being found during analysis the returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, an investigation conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that a uromax ultra dilation balloon catheter device was used during a retrograde intrarenal surgery (rirs) procedure.Reportedly, the uromax balloon broke during inflation.Additionally, the balloon ruptured between 12 and 18 atmospheres (atm).The procedure was completed with another of the same device with no patient complications.

• 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: 22365294
• Report Number: 2124215-2025-43215
• Device Sequence Number: 9418120
• Product Code: EZN
• UDI-Device Identifier: 08714729341123
• UDI-Public: (01)08714729341123(17)260709(10)31980936
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K130804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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 Expiration Date: 07/09/2026
• Device Model Number: M0062251020
• Device Catalogue Number: 225-102
• Device Lot Number: 0031980936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2023
• 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