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

Model Number	M0063905000
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a dakota basket was used in the right kidney during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2022.During procedure, the basket failed to open completely.Another basket was used to removed the stone stuck inside the defective basket and completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block h2: additional information: b5 (event description) has been updated based on the additional information received.Block h6: impact code f2301 is being used to capture the reportable issue of additional device required.Block h10: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a dakota basket was used in the right kidney during a retrograde intrarenal surgery (rirs) procedure performed on june 23, 2022.During procedure, the basket failed to open completely.Another basket was used to removed the stone stuck inside the defective basket and completed the procedure.There were no patient complications reported as a result of this event.***additional information received on july 19, 2022*** the procedure was completed with another dakota basket.
Additional Manufacturer Narrative
Block h2: additional information: b5 (event description) has been updated based on the additional information received.Block h6: impact code f2301 is being used to capture the reportable issue of additional device required.Block h10: the returned dakota basket was analyzed, and a visual evaluation noted that the basket returned in closed state.It was observed that the handle and sheath are in good condition.During the functional assessment, only 2 basket wires deployed correctly.In addition, during magnification, it was found that one of the basket wires is kinked.The video provided by the customer shows the dakota out of its original pouch and is possible observed that the basket cannot open completely.The reported event was confirmed.Based on all available information, it is possible that operational factors such as handling or manipulation, interaction with other device, and excess of force applied during it use could have caused basket wire kink.At the same time, the issue found avoided the correct deployment of all basket wires (basket could not open completely) causing the reported allegation and consequently affect the performance of the device.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a dakota basket was used in the right kidney during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2022.During procedure, the basket failed to open completely.Another basket was used to removed the stone stuck inside the defective basket and completed the procedure.There were no patient complications reported as a result of this event.***additional information received on july 19, 2022*** the procedure was completed with another dakota basket.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15041426
• Report Number: 3005099803-2022-03820
• Device Sequence Number: 12492615
• Product Code: FFL
• UDI-Device Identifier: 08714729937364
• UDI-Public: 08714729937364
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• 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): 09/08/2022

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 Expiration Date: 03/30/2025
• Device Model Number: M0063905000
• Device Catalogue Number: 63057
• Device Lot Number: 0029145893
• 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: 06/24/2022
• Supplement Date Received by Manufacturer: 07/19/2022; 08/17/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 08/03/2022; 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female