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

Model Number	M0062251070
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a041001 captures the reportable investigation result of balloon pinhole.Block h11: investigation results the returned uromax ultra balloon device was analyzed, and a visual evaluation noted that the balloon was not folded which indicates that the device was subjected to positive pressure.It was also noted that the returned device was attached to the customer's encore inflation unit.Additionally, a positive pressure was applied using deionized water and a balloon pinhole leak was noted 18mm distal from the proximal markerband.The rated burst pressure of this device was 20 atmospheres.A visual and tactile examination was performed on the shaft and found kink 25mm proximal from the distal tip.No issue was found with the tip of the device.A labeling review was performed, and the device was used for a transurethral ureteroscopy laser lithotripsy which is a procedure to treat kidney stones.There is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).Based on the available information, it is possible that the device had an interaction with a ureteral stone as the user was attempting to position it causing the pinhole leak in the balloon material so the complaint incident can be confirmed.Therefore, the most probable root cause is adverse event related to patient condition.
Event or Problem Description
It was reported that a uromax ultra dilation balloon catheter device was used during a transurethral ureteroscopic laser lithotripsy procedure.During the procedure it was noticed that it had a small hole on the catheter, and the water flowed out.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 18mm distal from the proximal markerband.

• 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: 22091804
• Report Number: 2124215-2025-34462
• Device Sequence Number: 6917188
• Product Code: EZN
• UDI-Device Identifier: 08714729341178
• UDI-Public: (01)08714729341178(17)260927(10)32524276
• 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): 05/27/2025

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: 09/27/2026
• Device Model Number: M0062251070
• Device Catalogue Number: M0062251070
• Device Lot Number: 0032524276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 86 KG