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

Model Number M0063905010

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of basket wire break has completely detached and was retrieved from the patient,.

Event Description

It was reported to boston scientific corporation that the dakota basket was used during procedure performed on (b)(6) 2023.During a procedure, the dakota basket broke off inside the patient near the right ureter.The physician successfully located and removed all the broken pieces of the basket.No additional fragments were found during the procedure.The collected basket fragments were securely packaged in a bag for reporting and further investigation.There were no patient complications as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of basket wire break has completely detached and was retrieved from the patient.Block h10: the returned trapezoid basket was analyzed, and a visual evaluation it was noted that both the sheath and the pull wire were disconnected from their respective notch.Additionally, there was a detached section located between the notch and the basket wires, along with a detached basket wire.Moreover, the sheath exhibited a kink in the distal section.Then during a magnification observed closely the device issues.Residues were observed as a part of the procedure, and there was noticeable evidence of melted material, potentially resulting from the use of a laser or an electrified instrument.The reported event was not confirmed.Based on all available information, it is possible to conclude some that operational factors, handling/manipulation, such as interaction with an electrified instrument and/or laser could cause the overheating of the device components resulting in the detachments observed.This breakage could have led the sheath bent/kink issue.Therefore, the most probable root cause is failure to follow instructions.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, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that the dakota basket was used during procedure performed on (b)(6) 2023.During a procedure, the dakota basket broke off inside the patient near the right ureter.The physician successfully located and removed all the broken pieces of the basket.No additional fragments were found during the procedure.The collected basket fragments were securely packaged in a bag for reporting and further investigation.There were no patient complications as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: DAKOTA
• Type of Device: 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: 17165573
• MDR Text Key: 317638963
• Report Number: 3005099803-2023-03377
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729937371
• UDI-Public: 08714729937371
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0063905010
• Device Catalogue Number: 63057
• Device Lot Number: 0031272601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention