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

Model Number	M0063905000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
Type of Reportable Event	Serious Injury
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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a dakota retrieval basket was used in the lumbar ureter during a flexible ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a piece of the basket's end effector broke and detached into the patient's ureter.Another dakota was used to retrieve the detached piece.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device code 2907 captures the reportable event of basket end effector detached.Block h10: visual inspection of the returned device found two end effector wires completely broken and one end effector leg detached.The broken end effector wires and end effector leg were not returned.One of the end effector wires had evidence of bending, and one section of the end effector leg was slightly torn, indicating the device was submitted to tension forces.Broken ends of the wires were inspected under magnification and evidence of necking (tensile deformation) was observed on the wires, indicating the material was submitted to strain.Also, the sheath was bent at several locations of the distal section.Based on all available information, it is most likely that procedural or anatomical factors encountered during the procedure likely affected the device's performance and integrity.Handling and manipulation of the device can lead to the sheath kinking at the distal section.Also, evidence observed in the broken ends of the wires suggests that the device was submitted to strain, and this condition could have damaged the grasper wire, end effector wires, and end effector leg.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed, and there is no evidence that the device was not used in accordance with the labeling/dfu.
Event or Problem Description
It was reported to boston scientific corporation that a dakota retrieval basket was used in the lumbar ureter during a flexible ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a piece of the basket's end effector broke and detached into the patient's ureter.Another dakota was used to retrieve the detached piece.There were no patient complications 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
• MDR Report Key: 9911582
• Report Number: 3005099803-2020-01356
• Device Sequence Number: 11621755
• Product Code: FFL
• UDI-Device Identifier: 08714729937364
• UDI-Public: 08714729937364
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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: 10/14/2022
• Device Model Number: M0063905000
• Device Catalogue Number: 63057
• Device Lot Number: 0024598986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention