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

Model Number	M0063905000
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable investigation result of basket wire fully detached.Block h11: investigation results.The returned dakota basket was analyzed, and the handle returned in good condition.A visual evaluation noted that the device returned with the grasper on its open position and the sheath returned free of bents or kinks.However, it was possible to observe that the strain relief returned kinked.Microscopic examination was performed under magnification, and it was noticed that the grasper was able to open; however, one of the grasper wires remained inside when the grasper was open.Analysis of x-ray was taken, and it was noticed that one of the long leg grasper wires was tangled inside the sheath.Destructive test was performed and using a cutting plier the grasper was cut to remove the handle cannula from the device to see the condition of the grasper wires.The device was disassembled and found that one of the long leg grasper wires was fully detached from the assemble, indicating that the component was submitted to tension.With all the available information, boston scientific concludes that the reported event of was confirmed.Based on the investigation results, all the observe findings could be related with handling and manipulation of the device during procedure.Therefore, taking all available information into consideration, the most probable cause of this complaint is cause traced to component failure since the failure of the device component is not related to any design or manufacturing issue.
Event or Problem Description
It was reported that a dakota retrieval basket was used during a cysto litho laser procedure.During the procedure, the basket did not open completely.The procedure was completely with another of the same device with no patient complications.However, investigation of the returned device revealed that one of the long leg grasper wires was broken and fully detached from the assemble.

• 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: 23555177
• Report Number: 2124215-2025-82585
• Device Sequence Number: 9829489
• Product Code: FFL
• UDI-Device Identifier: 08714729937364
• UDI-Public: (01)08714729937364(17)271108(10)35241580
• 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): 11/14/2025

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: 0035241580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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