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

Model Number	M0063903100
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	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of stone cone stone cone tip detachment.
Event or Problem Description
It was reported to boston scientific corporation that a nitinol retrieval coil was used in ureteral stone retrieval procedure performed on (b)(6) 2024.During the procedure, the tip of the stone cone fell off.It is unknown if this was caused by the hit of the laser.The tip was retrieved and the procedure was completed with this device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of stone cone stone cone tip detachment.Block h10: investigation results: the returned stone cone was analyzed, and a visual evaluation noted that the coil, sheath, working length, and handle had no defects.Functional examination was performed, and the coil was able to open and close without any issues.The analysis of the device did not identify any defects or breakage, therefore reported device allegation could not be confirmed.A device history record review confirmed that the device met all manufacturing specifications prior to distribution.Based on analysis results, a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported to boston scientific corporation that a nitinol retrieval coil was used in ureteral stone retrieval procedure performed on (b)(6) 2024.During the procedure, the tip of the stone cone fell off.It is unknown if this was caused by the hit of the laser.The tip was retrieved and the procedure was completed with this device.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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18857443
• Report Number: 2124215-2024-12855
• Device Sequence Number: 12832660
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: 08714729430209
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2025
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Device Lot Number: 0006924942
• 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: 02/15/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown