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	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The returned dakota grasper was analyzed, and a visual inspection noted that the sheath did not present any visual damage.A functional inspection found the grasper did not open.The thread cap was disassembled and the pull wire was removed from the sheath, and the pull wire was found broken.No other problems were noted.The two video clips shows one dakota with the grasper in a close or retracted position.However, the user actuated the device and the grasper did not open.The reported event was confirmed.Based on all available information, it is impossible to ascertain if the failure was cause due to incorrect handling of the product or prior to this since the package was received already open.Most likely, procedural factors as handling of the device prior to use could have lead to the reported event.Therefore, the most probable root cause is cause not established.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a dakota basket was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2021.During preparation, the basket failed to open.A video clip was provided showing the basket failed to open.The procedure was completed successfully.There were no patient complications as a result of this event.Investigation results revealed the pull wire was broken; therefore, this is now an mdr reportable event.
Additional Manufacturer Narrative
Block e1 initial reporter city: (b)(6) block h2: additional information: b5 event description block h6: device code a0401 captures the reportable investigation finding of pull wire break.Block h10: the returned dakota grasper was analyzed, the thread cap was disassembled and the pull wire was removed from the sheath, and the pull wire was found broken.No other problems were noted.The two video clips shows one dakota with the grasper in a close or retracted position.However, the user actuated the device and the grasper did not open.The reported event was confirmed.Based on all available information, it is impossible to ascertain if the failure was cause due to incorrect handling of the product or prior to this since the package was received already open.Most likely, procedural factors as handling of the device prior to use could have lead to the reported event.Therefore, the most probable root cause is cause not established.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a dakota basket was used in the ureter during a ureteroscopy procedure performed on(b)(6), 2021.During preparation, the basket failed to open when the physician tried to open it.The procedure was completed successfully.There were no patient complications as a result of this event.Investigation results revealed the pull wire was broken; therefore, this is now an mdr reportable event (see block h10 for investigation details).***additional information received on (b)(6), 2021*** 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
• MDR Report Key: 12468097
• Report Number: 3005099803-2021-04785
• Device Sequence Number: 19736159
• Product Code: FFL
• UDI-Device Identifier: 08714729937364
• UDI-Public: 08714729937364
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 08/06/2022
• Device Model Number: M0063905000
• Device Catalogue Number: 63057
• Device Lot Number: 0024226470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1