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	09/27/2024
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 h6: device code a0414 captures the reportable event sheath torn at distal end.
Event or Problem Description
It was reported that a nitinol retrieval coil device was used during a holmium laser lithotripsy for ureteral calculi procedure.It was reported that the device could not be deployed normally inside the patient, and it was taken out.However, it was found that the tip of the basket was fractured.The procedure was completed with another of the same device with no patient complications.
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 h6: device code a0414 captures the reportable event sheath torn at distal end.Block h11: investigation results the returned stone cone was analyzed, and a visual evaluation noted that the coil was received in close state.It was also noted that the blue sheath was pushed passed the distal stop.Functional examination was performed and upon opening the coil it could not be done due to resistance.With all the available information, boston scientific concludes that the reported event of sheath torn material was not confirmed.Based on the investigation, there was no torn material along the body of the device; however, the sheath was extended past the distal stop.It is likely that while testing the device before use after it was unpacked, excessive force on the outer sheath caused it to extend past the positive stop, this contradicts the instructions to advance the sheath to the positive stop, and the coil was not able to open or close.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.
Event or Problem Description
It was reported that a nitinol retrieval coil device was used during a holmium laser lithotripsy for ureteral calculi procedure.It was reported that the device could not be deployed normally inside the patient, and it was taken out.However, it was found that the tip of the basket was fractured.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: 20577849
• Report Number: 2124215-2024-67408
• Device Sequence Number: 8170524
• 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,Followup
• Report Date (Section B): 01/21/2025

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: 0008737029
• 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: 12/30/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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: Female