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

Model Number	M0063903200
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a040506 captures the reportable event of the tip was fractured.
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 ureteroscopic lithotripsy procedure performed on (b)(6) 2023.During the procedure, the coil could not be retracted, and the tip was fractured.The problem occurred outside the patient.Another stone cone was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a040506 captures the reportable event of the tip was fractured.Block h10: the returned stone cone was analyzed, and a visual inspection found the blue sheath was completely removed from the cone body.In addition, the green/blue sheath above the cone was detached as well.Functional testing could not be performed due to the separation of the blue sheath.The reported event was confirmed.Based on all available information, it is most likely that when the cone was tested, the separation of the blue and the blue/green sheath from the cone body was caused by excessive force or manipulation.The instruction 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." a labeling review was performed and there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).Based on all the available information, the investigation conclusion code is unintended use error, indicating that interaction between the user and the device caused or contributed to the error.
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 ureteroscopic lithotripsy procedure performed on (b)(6) 2023.During the procedure, the coil could not be retracted, and the tip was fractured.The problem occurred outside the patient.Another stone cone was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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 ; 5086834015
• MDR Report Key: 17686904
• Report Number: 3005099803-2023-04713
• Device Sequence Number: 6531585
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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: 02/02/2024
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0006244149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 65 KG