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

Model Number	M0063903200
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block e1: initial reporter facility name: (b)(6) hospital.Block h6: device code a0501 captures the reportable event of coil detached.
Event or Problem Description
It was reported that a stone cone retrieval coil device was about to be used during a ureteroscopic lithotomy procedure.Reportedly, during preparation it was found that the device had no stone taking basket.It was noted that the coil was disconnected when opened.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Initial reporter facility name: (b)(6).Device code a0501 captures the reportable event of coil detached.Investigation results: the returned stone cone was analyzed, and a visual evaluation noted that the coil had no defects.Functional examination was performed, and it was able to open and close with no problem.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 inspect the coil assembly for any visible damage.Prior to use, ensure that the coil is working properly by advancing the sheath over the coil to the positive stop and then retracting the sheath to open the coil.The sheath of the device should be straight during testing.With all the available information, boston scientific concludes that the reported event of was not confirmed since the analysis of the device did not find any defects or breakage; the device was able to close and open.Based on analysis results, an investigation conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that a stone cone retrieval coil device was about to be used during a ureteroscopic lithotomy procedure.Reportedly, during preparation it was found that the device had no stone taking basket.It was noted that the coil was disconnected when opened.The procedure was completed with another of the same device 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: 22385091
• Report Number: 2124215-2025-43571
• Device Sequence Number: 17926733
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: (01)08714729430223(17)270719(10)9198136
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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 Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0009198136
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• 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