MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPEN END URETERAL AXXCESS CATHETER; CATHETER, URETHRAL

Model Number	M0064001161
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a ureteral axxcess catheter device was used during a procedure.Reportedly, the ureteral catheter broke.No further information was reported.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of catheter break.
Event or Problem Description
It was reported that a ureteral axxcess catheter device was used during a procedure.Reportedly, the ureteral catheter broke.No further information was reported.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of catheter break.Block h11: investigation results: the axxcess ureteral catheters was returned for analysis and a visual evaluation noted that the device returned detached in two pieces and kinked.Microscopic examination was performed under magnification, and it was possible to see that the device was detached and kinked.With all the available information, boston scientific concludes that the reported event was confirmed.It is possible to conclude that this could be related to handling and manipulation of the device during procedure, it is probable that an excess of force applied to the device such as operational factors during their use could lead to detach and kink.Based on the analysis results, an investigation conclusion code of adverse event related to procedure was assigned to this investigation since the adverse event occurred during the procedure and the device had no influence on the event.

• Brand Name: OPEN END URETERAL AXXCESS CATHETER
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23208747
• Report Number: 2124215-2025-69979
• Device Sequence Number: 13259063
• Product Code: GBM
• UDI-Device Identifier: 08714729191971
• UDI-Public: (01)08714729191971(17)271118(10)32887867
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K830840
• 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,Followup
• Report Date (Section B): 03/03/2026

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: M0064001161
• Device Catalogue Number: 400-116
• Device Lot Number: 0032887867
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2023
• 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: Female