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

Model Number	M0063905000
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event basket wire detached.
Event or Problem Description
It was reported to boston scientific corporation that a dakota retrieval basket was about to be used during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6), 2023.During preparation, it was found that the wire of the basket was detached.The procedure was completed with another dakota retrieval basket device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event basket wire detached.Block h2: additional information: block d7a and block h8 have been updated based on additional information received january 15, 2024.
Event or Problem Description
It was reported to boston scientific corporation that a dakota retrieval basket was about to be used during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2023.During preparation, it was found that the wire of the basket was detached.The procedure was completed with another dakota retrieval basket device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event basket wire detached.Block h10: investigation results the returned dakota basket was analyzed, and a visual evaluation noted that one of the basket wires was broken and fully detached.Microscopic examination was performed, and it was noticed that the sheath was bent/kinked at the distal section.Functional examination was performed, and the handle was actuated.Additionally, the basket was able to open and close.With all the available information, boston scientific concludes that the reported event is confirmed as one of the basket wires of the dakota was broken and fully detached.This could be related to handling and manipulation of the device during preparation, it is probable that an excess of force applied to the device such as operational factors during their use could lead to break the basket wire.There are some inspections stating such as, inspect that wires are free to move distally along axis of device before basket begins to open.Cycle the basket handle slide in nest from open to closed position twice pressing trigger in open position after each cycle.Inspect basket wires do not bow radially inwards when trigger is engaged per vds radial inward bowing.All these inspections ensure that the basket wires are in good conditions and function as expected.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported to boston scientific corporation that a dakota retrieval basket was about to be used during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2023.During preparation, it was found that the tip of the device was detached.The procedure was completed with another dakota retrieval basket device.There were no patient complications reported as a result of this 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: 18437773
• Report Number: 2124215-2023-74391
• Device Sequence Number: 17898479
• Product Code: FFL
• UDI-Device Identifier: 08714729937364
• UDI-Public: 08714729937364
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2024

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 Expiration Date: 09/24/2026
• Device Model Number: M0063905000
• Device Catalogue Number: 63057
• Device Lot Number: 0032502658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 02/05/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/01/2024; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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