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

Model Number	M0062251170
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
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 a140101 captures the reportable event of balloon would not deflate.Block h11: investigation results: the product was not returned for analysis; therefore, complaint event is not confirmed since it did not include a returned device or media review to identify any problem that confirms the reported allegation.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Based on the available information, the most probable cause of the reported issue cannot be established due to lack of evidence.Additionally, without proper evaluation of the device, it remains unknown the most probable cause that contributed to the event.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Taking all available information into consideration an investigation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that a uromax ultra dilation balloon catheter device was used in a procedure.Reportedly, the balloon device was inflated as intended; however, it did not deflate.The device was withdrawn while still in an expanded state within the ureter.The procedure was completed with another of the same device.
Additional Manufacturer Narrative
Block h2: additional information: block a2, block b3, block b5 and block d7a.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 a140101 captures the reportable event of balloon would not deflate.Block h11: investigation results the product was not returned for analysis; therefore, complaint event is not confirmed since it did not include a returned device or media review to identify any problem that confirms the reported allegation.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Based on the available information, the most probable cause of the reported issue cannot be established due to lack of evidence.Additionally, without proper evaluation of the device, it remains unknown the most probable cause that contributed to the event.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Taking all available information into consideration an investigation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that a uromax ultra dilation balloon catheter device was used during a ureteroscopy (urs) procedure.Reportedly, the balloon device was inflated as intended; however, it did not deflate.The device was withdrawn while still in an expanded state within the ureter.The procedure was completed with another of the same device.

• 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: 24839696
• Report Number: 2124215-2026-19576
• Device Sequence Number: 13169493
• Product Code: EZN
• UDI-Device Identifier: 08714729341253
• UDI-Public: (01)08714729341253
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: M0062251170
• Device Catalogue Number: M0062251170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/12/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/08/2026
• 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: 55 YR
• Patient Sex: Unknown