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

Model Number	M0063905000
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
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) 2024.During preparation, it was found that the basket wire was broken and detached.The procedure was completed with another dakota retrieval basket device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of basket wire detached.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of basket wire break.Block h10: investigation results the returned dakota basket was analyzed, and a visual evaluation noted that the basket was on its closed position.Microscopic examination was performed, and it was noticed that one basket wires was broken and not fully detached.It was also noted that the basket wire was melted.Functional examination was performed, and the handle was actuated.Additionally, the basket was able to open and closed.A labeling review was performed and, from the information available the device was used in a manner inconsistent with the labelled indications.The ifu states that, this device must not come in contact with any electrified instrument; however, after the analysis performed, there was evidence that the basket wire was melted.The ifu contains detailed device information and instructions for the device use and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.With all the available information, boston scientific concludes that the reported event of basket wire break was confirmed.It is possible to conclude that some operational factors, handling/manipulation, such as interaction with an electrified instrument and/or laser could cause the overheating of the basket wire resulting in the breakage.Based on the investigation results, the most probable root cause of failure to follow instructions was assigned to this investigation.
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) 2024.During preparation, it was found that the basket wire was broken and detached.The procedure was completed with another dakota retrieval basket device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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) 2024.During preparation, it was found that the basket wire was broken and detached.The procedure was completed with another dakota retrieval basket device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of basket wire break.H6.Device code corrected.

• 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: 18587059
• Report Number: 2124215-2024-03944
• Device Sequence Number: 7140104
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2024

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: 07/24/2026
• Device Model Number: M0063905000
• Device Catalogue Number: 63057
• Device Lot Number: 0032086885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 02/01/2024; 03/11/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 02/21/2024; 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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 Age: 62 YR
• Patient Sex: Male