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

Model Number	M0063903200
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a stone cone retrieval coil device was found damaged.Reportedly, the packaging was not intact and compromised resulting in sterility issue.No patient was involved at the time of the event.
Additional Manufacturer Narrative
Block b3: date of event was approximated to 02/01/2025 based on the date the manufacturer became aware of the event.Block h6: device code a020503 captures the reportable event of seal compromise.
Additional Manufacturer Narrative
Block b3: date of event was approximated to 02/01/2025 based on the date the manufacturer became aware of the event.Block h6: device code a020503 captures the reportable event of seal compromise.Block h11: investigation results: the returned unused stone cone was analyzed, and a visual evaluation noted that the device package had tear.Media analysis was performed on the picture provided by the customer and shows that the device packaging was torn.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu)/product label.The ifu states that, before using inspect the blister pouch for any breach of the package to ensure a sterile product and inspect product for any damage.If seal has been broken or product is damaged do not use.Immediately return package and product to boston scientific.With all the available information, boston scientific concludes that the reported event was confirmed.The device packaging torn is likely due to the damage occurred after the device was packaged during manufacturing but prior to use of the device.Based on the investigation results and information available, an investigation conclusion code of cause traced to transport/storage was assigned to this investigation which indicates problems traced to the inappropriate transport or storage of the device.
Event or Problem Description
It was reported that a stone cone retrieval coil device was found damaged.Reportedly, the packaging was not intact and compromised resulting in sterility issue.No patient was involved at the time of the 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: 21819403
• Report Number: 2124215-2025-21551
• Device Sequence Number: 15645610
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: (01)08714729430223(17)270805(10)9227881
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: 0009227881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2024
• 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