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

Model Number	M0063903200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter address (b)(6).Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a transurethral lithotripsy procedure performed on (b)(6) 2023.During the procedure, the sheath was damaged outside the patient.There were no more stone cone available; therefore, the procedure was aborted.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter address (b)(6).Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: a stone cone was received for analysis.A visual inspection observed the area of the cone with the white sheath and handle was completely separated from the rest of the body.The cone was received in an open state and a tangle was noted on the cone.The sheath around the cone was peeled.The reported event was confirmed.Based on the defects observed during analysis, it is most likely that the damage was caused by excessive force or manipulation.The tangled noted on the cone could prevent the cone from fully closing/opening.It is probable that force was exerted when they were testing the cone causing the wiring deformation and leading to the body break.Additionally, the instructions for use (ifu) states, "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." therefore, the complaint investigation conclusion code selected is unintended use error, indicating that interaction between the user and the device caused or contributed to the error.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu) / labeling.
Event or Problem Description
It was reported that a stone cone nitinol retrieval coil was used in the ureter during a transurethral lithotripsy procedure performed on (b)(6) 2023.During the procedure, the sheath was damaged outside the patient.There were no more stone cone available; therefore, the procedure was aborted.There were no patient complications reported as a result of this event.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17108236
• Report Number: 3005099803-2023-03161
• Device Sequence Number: 6244289
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 08/10/2023

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: 05/24/2025
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0007261155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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