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

Model Number	M0063905000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was reported by the distributor.The physician present for this case was: (b)(6).(b)(4).The returned dakota grasper was analyzed, and a visual inspection noted that the grasper was in close or retracted position when received.The sheath was found kinked/bent at the distal section.Additionally, the grasper was torn and the pull wire was broken.No other problems were noted.The reported event was confirmed.Based on all available information, it is possible that operational factors such as manipulation or interaction with the scope could have caused the sheath kinked.Also the sheath kinked, excessive force applied, many attempts to gripping the stone, the friction and the resistance created can cause pull wire broke and the grasper torn.As a consequence, the performance of the device was affected.Therefore, the most probable root cause is adverse event related to procedure.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.
Event or Problem Description
It was reported to boston scientific corporation that a dakota basket was used in the ureter during a urolithiasis crushing procedure performed on (b)(6) 2021.During procedure, after a few times gripping the stone, the basket wire broke.The basket wires were still attached at the other end.The procedure was completed with another dakota basket.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: (b)(6) block e1 : additional information: (b)(6) block h6: device code a0401 captures the reportable investigation finding of pull wire break.Block h10: the returned dakota grasper was analyzed, and a visual inspection noted that the grasper was in close or retracted position when received.The sheath was found kinked/bent at the distal section.Additionally, the grasper was torn and the pull wire was broken.No other problems were noted.The reported event was confirmed.Based on all available information, it is possible that operational factors such as manipulation or interaction with the scope could have caused the sheath kinked.Also the sheath kinked, excessive force applied, many attempts to gripping the stone, the friction and the resistance created can cause pull wire broke and the grasper torn.As a consequence, the performance of the device was affected.Therefore, the most probable root cause is adverse event related to procedure.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.
Event or Problem Description
It was reported to boston scientific corporation that a dakota basket was used in the ureter during a urolithiasis crushing procedure performed on (b)(6), 2021.During procedure, after a few times gripping the stone, the basket wire broke.The basket wires were still attached at the other end.The procedure was completed with another dakota basket.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).

• 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: 12548108
• Report Number: 3005099803-2021-05003
• Device Sequence Number: 11037979
• Product Code: FFL
• UDI-Device Identifier: 08714729937364
• UDI-Public: 08714729937364
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/11/2021

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: 05/16/2024
• Device Model Number: M0063905000
• Device Catalogue Number: 63057
• Device Lot Number: 0027328756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1