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	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a040506 captures the reportable coating fractured.
Event or Problem Description
It was reported to boston scientific corporation that a nitinol retrieval coil device was about to be used during a ureteral calculi procedure performed on (b)(6) 2024.During preparation, upon opening the package the sealing and coating end of the basket was fractured.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a040506 captures the reportable coating fractured.Block h11: investigation results the returned stone cone was analyzed, and a visual evaluation noted that the coil was received in an open state and was tangled.Additionally, it was found that the sheath around the coil was peeled exposing the shaft wire.Functional examination was performed, and when trying to close the coil resistance was encountered due to the tangle area.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 by using excessive force or manipulation.It is probable that when they were testing the coil force was exerted causing the wiring deformation and sheath damage that was observed in the analysis.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 to boston scientific corporation that a nitinol retrieval coil device was about to be used during a ureteral calculi procedure performed on (b)(6) 2024.During preparation, upon opening the package the sealing and coating end of the basket was fractured.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient condition following 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: 19074177
• Report Number: 2124215-2024-21424
• Device Sequence Number: 15178483
• 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): 09/26/2024

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: 08/29/2026
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0008597090
• 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: 03/20/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 65 KG