MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DUAL LUMEN URETERAL CATHETER; CATHETER, UROLOGICAL

Model Number	M0064051000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two dual lumen ureteral catheter were used during a ureteroscopy procedure.During insertion, the surgeon noticed some damage to the outside of it where some of the main shaft had split and was sticking up.Additionally, a second dual lumen catheter was inserted, and the surgeon noticed the catheter split.The procedure was completed with another of the same device with no patient complications.This report pertains to the first of two dual lumen ureteral catheter devices used in the same patient and procedure.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of catheter break.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of catheter break.Block h11: investigation results the returned dual lumen ureteral catheter was analyzed, and it was not possible to observe any brakeage on the catheter or any damage in general.Media analysis was performed with the pictures provided by the customer and the dual lumen ureteral catheter showed that the tip was torn.Microscopic examination was performed under magnification, and the catheter tip was in good condition and no issues 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 not confirmed since it was not possible to identify any evidence of either the alleged issue or any defect on the device and the evidence from the product record review did not identify a potential product quality issue or new patient harm.Additionally, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Also, a risk review found the issue reported as expected and detailed in the risk documentation.A labeling review confirmed the ifu includes appropriate instructions for use.Based on analysis results, an investigation conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that two dual lumen ureteral catheter were used during a ureteroscopy procedure.During insertion, the surgeon noticed some damage to the outside of it where some of the main shaft had split and was sticking up.Additionally, a second dual lumen catheter was inserted, and the surgeon noticed the catheter split.The procedure was completed with another of the same device with no patient complications.This report pertains to the first of two dual lumen ureteral catheter devices used in the same patient and procedure.

• Brand Name: DUAL LUMEN URETERAL CATHETER
• Common Device Name: CATHETER, UROLOGICAL
• 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: 21395930
• Report Number: 2124215-2025-07593
• Device Sequence Number: 12699359
• Product Code: KOD
• UDI-Device Identifier: 08714729012689
• UDI-Public: (01)08714729012689(17)280128(10)33309242
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K860337
• 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
• Report Date (Section B): 04/29/2025

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 Model Number: M0064051000
• Device Catalogue Number: M0064051000
• Device Lot Number: 0033309242
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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