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

Model Number	M0063903100
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0414 captures the reportable event of sheath torn.
Event or Problem Description
It was reported to boston scientific corporation that a nitinol retrieval coil device was used during a ureteroscopy procedure performed on (b)(6) 2024.During the procedure, it was found that the sheath was torn upon opening the package.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of sheath torn.H2: additional information block b5 (describe event or problem) block d7a (sud reprocessed and reused) block h8 (usage of device).
Event or Problem Description
It was reported that a nitinol retrieval coil device was used during a ureteroscopy procedure.During the procedure, it was found that the sheath was torn at the proximal section close to the mid of the sheath.The procedure was completed with another of the same device and there were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of sheath torn.Block h11: investigation results: the returned stone cone was analyzed, and a visual evaluation noted that the coil was received in an open state.It was also noted that the blue sheath was broken exposing the white sheath.Functional examination was performed, and the coil was able to fully open and close even though the blue sheath was broken.A labeling review was performed and, there is no evidence that this device was not used in accordance with instructions for use.With all the available information, boston scientific concludes that the reported event was confirmed.Based on the investigation it is most likely that the damage was caused during the test of the device with the use of excessive force or manipulation.When force was exerted when trying to open/close the coil, the blue sheath broke.Additionally, the 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 most probable root cause of unintended use error caused or contributed to event was assigned to this investigation.
Event or Problem Description
It was reported that a nitinol retrieval coil device was used during a ureteroscopy procedure.During the procedure, it was found that the sheath was torn at the proximal section close to the mid of the sheath.The procedure was completed with another of the same device and 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: 19052987
• Report Number: 2124215-2024-20572
• Device Sequence Number: 17909633
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: 08714729430209
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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,Followup
• Report Date (Section B): 06/18/2024

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: 07/03/2026
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Device Lot Number: 0008494275
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 05/29/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 04/24/2024; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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: Unknown