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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of basket wire detached.
Event or Problem Description
It was reported that a dakota basket was used during a ureteroscopy procedure.During the procedure, the basket broke off and the end effector wire detach completely from the grasper inside the patient.The wire had to be retrieved with a second basket and no pieces were left inside the patient.The procedure was completed with another of the same device with no patient complications.
Event or Problem Description
It was reported that a dakota basket was used during a ureteroscopy procedure.During the procedure, the basket broke off and the end effector wire detach completely from the grasper inside the patient.The wire had to be retrieved with a second basket and no pieces were left inside the patient.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of basket wire detached.Block h11: investigation results the returned dakota was analyzed, and a visual evaluation noted that the handle returned in good condition.However, the grasper returned completely detached from the device.It was also noted that, the strain relief was bent.Microscopic examination was performed under magnification, and it was noticed that the strain relief returned stretched indicating it was submitted to tension.Additionally, the sheath was bent in the center.The grasper was completely detached and only two grasper wires left attached to the sheath.It was also found that the grasper wires are broken, however, there is evidence of glue in the grasper indicating it was attached to the sheath initially.With all the available information, boston scientific concludes that the reported event was confirmed.These could be related to handling and manipulation of the device during procedure, it is probable that an excess of force applied to the device such as operational factors during their use could cause all the damages observed.Taking all available information into consideration, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.

• 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: 20729011
• Report Number: 2124215-2024-71989
• Device Sequence Number: 20957194
• Product Code: FFL
• UDI-Device Identifier: 08714729937364
• UDI-Public: 08714729937364
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 03/24/2025

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: M0063905000
• Device Catalogue Number: M0063905000
• Device Lot Number: 0033656026
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose