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

Model Number	M0064051000
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: patient code e2015 captures the reportable event of ureteral injury.Impact code f23 captures the reportable event of unexpected medical intervention.Impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported that a dual lumen ureteral catheter device was used during a ureteroscopy procedure.During the procedure, a left ureteral injury occurred from the sharp tip device when attempting to access the ureter, and a non-boston scientific device was used to complete access to the ureter.Due to the ureteral injury, the lasing was not performed, and instead, a ureteral stent was placed.The patient will be evaluated again for ureteral stricture.
Additional Manufacturer Narrative
H2: additional information: a2, a3a, a3b, a5, a6, e4, g2.H6: patient code e2015 captures the reportable event of ureteral injury.Impact code f23 captures the reportable event of unexpected medical intervention.Impact code f2301 captures the reportable event of additional device required.H11: investigation results: the product was not returned for analysis; however, media analysis was performed; and it was not possible to confirm since an analysis at the laboratory needs to be performed to determine if there is a sharp tip or not.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.The instruction for use mentions perforation of kidney, renal pelvis, ureter and/or bladder as potential complications that may be associated with the use of the device.With all the available information, boston scientific concludes that the complaint event could not be confirmed since it did not include a returned device to identify any issue that could confirmed the reported allegation.However, since the device is not going to returned due to it was disposed, a deeper analysis of the device could not be performed.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.Additionally, without a proper evaluation of the device or objective evidence, it remains unknown the most probable causes that could have contributed to the event.As per additional information requested to the manufacturing team, during manufacturing process, device inspections are conducted to ensure the integrity of the device tip that would have captured any tip sharp.Taking all available information into consideration, an investigation conclusion code of cause not established was assigned to this investigation since the findings do not lead to a clear conclusion about the cause of the reported adverse event.
Event or Problem Description
It was reported that a dual lumen ureteral catheter device was used during a ureteroscopy procedure.During the procedure, a left ureteral injury occurred from the sharp tip device when attempting to access the ureter, and a non-boston scientific device was used to complete access to the ureter.Due to the ureteral injury, the lasing was not performed, and instead, a ureteral stent was placed.The patient will be evaluated again for ureteral stricture.

• Brand Name: NA
• 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: 22235639
• Report Number: 2124215-2025-38072
• Device Sequence Number: 9098803
• Product Code: KOD
• UDI-Device Identifier: 08714729012689
• UDI-Public: (01)08714729012689(17)290411(10)36289454
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0064051000
• Device Catalogue Number: M0064051000
• Device Lot Number: 0036289454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/02/2025
• Date Device Manufactured: 04/12/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White