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

Model Number	M0063903200
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	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during unpacking of a nitinol retrieval coil device, it was noted that the front of the device had no helix structure.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0501 captures the reportable event of coil detachment.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h2: additional information: block b5 (describe event or problem).Block h6: imdrf device code a0501 captures the reportable event of coil detachment.
Event or Problem Description
It was reported that during unpacking of a nitinol retrieval coil device, it was noted that the front of the device had no helix structure.The coil was nowhere to be found inside the packaging.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0501 captures the reportable event of coil detachment.Block h11: investigation results the returned stone cone was analyzed, and a visual evaluation noted that the coil was received in close state.It was also noted that the blue sheath was pushed passed the distal stop.Functional examination was performed and when trying to open the coil, it could not be done due to resistance.A labeling review was performed and the ifu states that, prior to use, ensure that the coil is working properly by advancing the sheath over the coil to the positive stop and then retracting the sheath to open the coil.The sheath of the device should be straight during testing.With all the available information, boston scientific concludes that the reported event was confirmed.Since the sheath was extended past the distal stop, the coil was pushed inside the blue sheath and it was not visible, so this is likely what the customer meant that there was no helix structure.It is probable that while testing the device before use after it was unpacked, excessive force on the outer sheath caused it to extend past the positive stop, and the coil was not able to open or close.Based on the information available and investigation results, an investigation conclusion code of unintended use error caused or contributed to event was assigned to this investigation indicating that interaction between the user and the device caused or contributed to the error.
Event or Problem Description
It was reported that during unpacking of a nitinol retrieval coil device, it was noted that the front of the device had no helix structure.The coil was nowhere to be found inside the packaging.The procedure was completed with another of the same device with no patient complications.

• 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: 20096952
• Report Number: 2124215-2024-53218
• Device Sequence Number: 7664862
• 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,Followup
• Report Date (Section B): 11/26/2024

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 Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0008693146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 08/29/2024; 11/05/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/26/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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