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

Model Number	M0064051000
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of catheter break.
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 second of two dual lumen ureteral catheter devices used in the same patient and procedure.
Additional Manufacturer Narrative
Device code a0401 captures the reportable event of catheter break.Investigation result: the returned dual lumen ureteral catheter was analyzed, and media analysis revealed with the pictures provided by the customer that the dual lumen ureteral catheter tip was torn.Additionally, a visual and microscopic evaluation noted that the returned catheter tip was torn.However, it was not possible to observe any brakeage on the catheter.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 of catheter break was not confirmed since it was not possible to identify any evidence of the alleged issue on the device and it was not possible to observe a breakage on the catheter.However, the observed findings of the dual lumen ureteral catheter tip was torn, this could be related to handling and manipulation of the device during insertion.It is probable that an excess of force applied to the device such as operational factors during their use and also the interaction with the other devices could lead to tear the tip.Additionally, on the manufacturing process, there are some inspections that ensure the integrity of the catheter tip and would have captured the failure encountered.Taking all available information into consideration, an investigation conclusion code of adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.
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 second 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: 21394414
• Report Number: 2124215-2025-07589
• Device Sequence Number: 8526321
• 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