MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DAKOTA; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063905000
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a dakota retrieval basket was used during a transurethral lithotripsy (tul) procedure.Reportedly, the device would not open or close after multiple tries.The procedure was completed with another of the same device with no patient complications.Analysis of the returned basket identified that the grasper returns detached from the sheath.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable investigation results of grasper detachment.Block h11: investigation result the returned dakota basket was analyzed, and a visual evaluation noted that the handle returned in good condition and the device returned with the grasper on its close position.Microscopic examination was performed under magnification, and it was noticed that the grasper was detached from the sheath.Functional examination was performed with the handle actuated, and the grasper was not able to open or close since the grasper was detached from the sheath.Destructive test was performed and there was evidence of torque mark.The device was disassembled, and the handle cannula was properly assembled to the pinch vise.Additionally, it was noted that the spring was in good condition.The grasper was removed from the distal end and noticed that the pull wire and the grasper properly assembled in the notch cannula.It was also noticed that crimp marks were present, indicating no visual defects were found internally.With all the available information, boston scientific concludes that the reported events were confirmed.Based on the investigation, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.However, during the analysis it was found the grasper detached from the sheath which consequently contributes that the grasper was not able to open or close and these findings did not lead to a clear conclusion about the cause of the problem.As per additional information requested to the manufacturing team, during manufacturing process, device inspections are conducted to ensure the integrity and functionality of the device that would have captured the encountered problems.Based on the analysis results, a 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 event.

• Brand Name: DAKOTA
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• 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: 23638969
• Report Number: 2124215-2025-85660
• Device Sequence Number: 18456174
• Product Code: FFL
• UDI-Device Identifier: 08714729937364
• UDI-Public: (01)08714729937364(17)280406(10)36241823
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/24/2025

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: M0063905000
• Device Catalogue Number: M0063905000
• Device Lot Number: 0036241823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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
• Patient Sex: Unknown