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

Model Number	M0063903200
Medical Device Problem Codes	Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used during a left transurethral ureteroscope laser lithotripsy procedure in the pyeloureter performed on (b)(6) 2024.During preparation, it was found that the coil coating was peeled off.The procedure was completed with another stone cone nitinol retrieval coil.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Imdrf a040506 captures the reportable event of coil coating was peeled off.
Additional Manufacturer Narrative
Block h6: imdrf a040506 captures the reportable event of coil coating was peeled off.Block h10: the returned stone cone nitinol retrieval coil was analyzed, and a visual evaluation noted the coil had a tangled area.The coil could not fully close due to the tangle.There was no fracture or peeling of the coil.The tangled noted on the cone prevented the cone from fully opening or closing.It is most likely the that the damage was caused by using excessive force or manipulation.It is probable that during testing of coil at the time of preparation, force was exerted causing the wiring deformation.The instructions for use indicates 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.The product analysis did not confirm the reported coil peeled.Based on the analysis results of observed coil tangled, an investigation conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
Event or Problem Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil during in a left transurethral ureteroscope laser lithotripsy procedure in the pyeloureter performed on (b)(6) 2024.During preparation, it was found that the coil coating was peeled off.The procedure was completed with another stone cone nitinol retrieval coil.There were no patient complications reported as a result of this event.The condition of the patient 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
• MDR Report Key: 19101358
• Report Number: 2124215-2024-21908
• Device Sequence Number: 15305665
• 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): 06/13/2024

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: 07/11/2026
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0008511705
• 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: 03/20/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 65 KG