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

Model Number	M0063903200
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	11/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a stone cone retrieval coil was about to be used during a ureteroscopic lithotomy procedure.Reportedly, the basket could not be deployed.The procedure was completed with another of the same device with no patient complications.Analysis of the returned device revealed that the sheath at coil end was peeled.
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 a0414 captures the reportable investigation result of coil/sheath torn.Block h11: investigation results the returned stone cone was analyzed, and a visual evaluation noted that the coil was received in the open state.It was also noted that the green/blue heath shrink was peeled and that the coil was tangled.Functional examination was performed and when trying to open the coil, it was noticed that it could not be done due to resistance.The instructions for use (ifu) states that if resistance is encountered while attempting to withdraw the coil do not exert excessive force.To release the object from the device, advance the sheath to straighten the coil and remove the device.With all the available information, boston scientific concludes that the reported event was confirmed.Based on the clear defects observed during product analysis, it is most likely that the damage was caused by using excessive force or manipulation.It is probable that when they were testing the coil force was exerted causing the wire to peel and become tangled.Taking all available information into consideration, the most probable cause of this complaint is unintended use error caused or contributed to event, indicating that interaction between the user and the device caused or contributed to the error.

• 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: 21698382
• Report Number: 2124215-2025-18060
• Device Sequence Number: 8773764
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• 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
• Report Date (Section B): 03/26/2025

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: 0009090181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2024
• 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