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

Model Number	M0062251070
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a uromax ultra balloon dilation catheter device was set for use in a transurethral ureteroscopic holmium laser lithotripsy procedure.During preparation, it was noticed that the balloon had a small hole and was leaking water.The procedure was completed with another of the same device with no patient complications.However, analysis of the returned device revealed that a balloon pinhole leak was noted approximately 12mm proximal from the distal markerband.
Additional Manufacturer Narrative
Block h6: device code a041001 captures the reportable investigation result of balloon pinhole.Block h11: investigation results the returned uromax ultra device was analyzed and a visual examination noted that the balloon was not folded which indicates that the device was subjected to positive pressure.It was also noted that device was attached to the encore inflation unit and carried out with a positive pressure using a de-ionized water.However, a balloon pinhole leak was noted approximately 12mm proximal from the distal markerband.Additionally, the rated pressure of the balloon was 20 atmospheres.A visual and tactile examination were performed to the tip and the shaft of the device, and no kinks nor damage were found.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 confirmed.Based on the investigation results it's most likely that the probability of the device having an interaction with a sharp object/implement during preparation for the procedure which would have contributed to the balloon perforation.Therefore, an investigation conclusion code of unintended use error caused or contributed to event was assigned to this investigation.

• 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: 23475972
• Report Number: 2124215-2025-78267
• Device Sequence Number: 18691037
• Product Code: EZN
• UDI-Device Identifier: 08714729341178
• UDI-Public: (01)08714729341178(17)260925(10)32508010
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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: 09/25/2026
• Device Model Number: M0062251070
• Device Catalogue Number: M0062251070
• Device Lot Number: 0032508010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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