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

Model Number	M0063905010
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	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blocks d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.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.Additionally, the sheath was kinked at the distal section.Functional examination was performed with the handle actuated, and the grasper was unable to open or close due to grasper detachment from the sheath.With all the available information, boston scientific concludes that the reported event was confirmed.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.The observed findings that the sheath kinked at the distal section could be related to handling and manipulation of the device during procedure.It is possible that an excess of force applied to the device such as operational factors during their use could lead to kink the sheath.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.
Event or Problem Description
It was reported that a dakota retrieval basket was used during a ureteroscopic stone extraction procedure.Reportedly, the basket was opening and closing at first but then it stopped deploying.The procedure was completed with another of the same device with no patient complications.Analysis of the returned basket identified that the grasper was detached from the sheath.

• 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: 23671552
• Report Number: 2124215-2025-85677
• Device Sequence Number: 18570761
• Product Code: FFL
• UDI-Device Identifier: 08714729937371
• UDI-Public: (01)08714729937371
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2025

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: M0063905010
• Device Catalogue Number: M0063905010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• 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: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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