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

Model Number	M0062251070
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable event of balloon torn material.
Event or Problem Description
It was reported that a uromax ultra dilation balloon catheter device was used during a transurethral lithotripsy (tul) procedure.During the procedure, the balloon was pre-inflated before the insertion; however, the balloon was torn and deflated immediately.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h2: additional information: block d4 (model number, lot number, catalog number).Block h6: device code a0414 captures the reportable event of balloon torn material.
Event or Problem Description
It was reported that a uromax ultra dilation balloon catheter device was used during a transurethral lithotripsy (tul) procedure.During the procedure, the balloon was pre-inflated before the insertion; however, the balloon was torn and deflated immediately.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable event of balloon torn material.Block h11: investigation result: the returned uromax ultra device was analyzed, and a visual examination noted that the balloon was subjected to positive pressure.Additionally, a leak test was carried out using de-ionized water when liquid was observed to be exiting from the tip of the device.No issues were noted on the balloon material and the tip of the device.A visual and tactile examination was performed to the shaft of the device and it was noticed to be severely kinked and approximately 200mm of the proximal balloon sleeve.The identified leak from the tip is an indication of a breach between the wire lumen and the inflation lumen.The lumen breach is most probably located at the site of the kink.No other issues were identified with the shaft and the markerbands of the device.Both markerbands were undamaged and in the correct position on the shaft 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 confirmed.Based on the investigation, it was possible that the shaft kink occurred due to excessive force being applied when handling the device during preparation.The shaft kink would have created a weakness in the inner shaft which would have breached when positive pressure was applied during inflation.Therefore, the most probable root cause is unintended use error caused or contributed to event.
Event or Problem Description
It was reported that a uromax ultra dilation balloon catheter device was used during a transurethral lithotripsy (tul) procedure.During the procedure, the balloon was pre-inflated before the insertion; however, the balloon was torn and deflated immediately.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: 21106939
• Report Number: 2124215-2024-82906
• Device Sequence Number: 8758085
• Product Code: KOE
• UDI-Device Identifier: 08714729341178
• UDI-Public: 08714729341178
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 02/26/2025

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: 02/06/2026
• Device Model Number: M0062251070
• Device Catalogue Number: M0062251070
• Device Lot Number: 0030999622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 02/05/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/04/2025; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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