MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONE CONE; DISLODGER, STONE, FLEXIBLE

Model Number	M0063903100
Medical Device Problem Codes	Difficult to Open or Close (2921); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable event of sheath torn at distal end.
Event or Problem Description
It was reported that a nitinol retrieval coil device was used during a ureterolitotomia procedure.During the procedure, the device got fractured at the distal end.Additionally, the device end was stuck, and it was not functional.The procedure was completed with no patient complications.
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable event of sheath torn at distal end.
Event or Problem Description
It was reported that a nitinol retrieval coil device was used during a ureterolitotomia procedure.During the procedure, the device got fractured at the distal end.Additionally, the device end was stuck, and it was not functional.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable event of sheath torn at distal end.Block h11: investigation results the returned stone cone was analyzed, and a visual evaluation noted that the sheath above distal stop was broken off.Additionally, the coil was able to open and close with no issues.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.The ifu states to open the stone cone coil by holding the proximal end of the blue sheath with one hand and the white wire with the other.Advance the wire into the sheath to open the coil.Verify that the coil is fully open using fluoroscopy.To ensure that the coil is fully open, advance the wire until the white portion of the wire assembly is not visible.With all the available information, boston scientific concludes that the reported event was confirmed.Based on the investigation, it is most likely that the damage may have occurred due to manipulation of the device during the insertion of the device into the catheter.Therefore, an investigation conclusion code of unintended use error caused or contributed to event, was assigned to this investigation, indicating that interaction between the user and the device caused or contributed to the event.
Event or Problem Description
It was reported that a nitinol retrieval coil device was used during a ureterolitotomia procedure.During the procedure, the device got fractured at the distal end.Additionally, the device end was stuck, and it was not functional.The procedure was completed with no patient complications.

• Brand Name: STONE CONE
• Common Device Name: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): LAKE REGION MEDICAL; 31c butterfield trail; el paso TX 79906
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20574840
• Report Number: 2124215-2024-67398
• Device Sequence Number: 8574842
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: (01)08714729430209(17)260727(10)8540372
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 06/20/2025

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: 07/27/2026
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Device Lot Number: 0008540372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 05/27/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/27/2024; 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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
• Patient Sex: Unknown