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	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was to be used during a procedure performed on (b)(6) 2023.It was reported that the coil at the front end of the device was damaged and could not be used.The procedure was completed with another stone cone nitinol retrieval coil.There were no patient complications reported as a result of this event.The patient 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 coil damaged.
Event or Problem Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was to be used during a procedure performed on (b)(6) 2023.It was reported that the coil at the front end of the device was damaged and could not be used.The procedure was completed with another stone cone nitinol retrieval coil.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.***additional information received on november 13, 2023*** it was reported that the problem noticed when opening the package and before the procedure.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (describe event or problem) and block e1 (initial reporter's address) have been updated based on the additional information received on november 13, 2023.Block h6: imdrf device code a040506 captures the reportable event of coil damaged.
Additional Manufacturer Narrative
Block h6: imdrf device code a040506 captures the reportable event of coil damaged.Block h10: 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 above the coil was pushed up and accordioned exposing the shaft wire.Functional examination was performed, and a resistance was encountered when closing the coil due to the tangle area, so it was unable to close.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.With all the available information, boston scientific concludes that the reported event was confirmed.The investigation found 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 since the 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 to be used during a procedure performed on (b)(6) 2023.It was reported that the coil at the front end of the device was damaged and could not be used.The procedure was completed with another stone cone nitinol retrieval coil.There were no patient complications reported as a result of this event.The patient 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: 18135480
• Report Number: 2124215-2023-63528
• Device Sequence Number: 15040228
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 02/08/2024

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: 10/29/2025
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0007622127
• 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: 10/27/2023
• Supplement Date Received by Manufacturer: 11/13/2023; 01/17/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 11/30/2023; 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2022
• 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
• Patient Sex: Unknown