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

Model Number	M0063903100
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	12/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blocks d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0501 captures the reportable event of coil detachment.Impact code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported that a stone cone coil retrieval was used during the procedure.Reportedly, the retrieval coil distal tip fractured while still in situ.The tip was successfully retrieved, and no components were left in situ.There were no patient complications.
Event or Problem Description
It was reported that a stone cone coil retrieval was used during the procedure.Reportedly, the retrieval coil distal tip fractured while still in situ.The tip was successfully retrieved, and no components were left in situ.There were no patient complications.
Additional Manufacturer Narrative
Blocks d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0501 captures the reportable event of coil detachment.Impact code f23 captures the reportable event of unexpected medical intervention.Block h11: investigation results: the product was not returned for analysis therefore technical analysis could not be performed; however, media analysis shows that the distal end of the coil is fractured.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 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.With all the available information, boston scientific concludes that the reported event was confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Based on the investigation results, record review revealed no additional information related to the complaint.The results of record reviews did not provide evidence of a probable cause.This investigation was unable to determine a probable cause for the complaint event.Taking all available information into consideration an investigation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that a stone cone coil retrieval was used during the procedure.Reportedly, the retrieval coil distal tip fractured while still in situ.The tip was successfully retrieved, and no components were left in situ.There were no patient complications.
Additional Manufacturer Narrative
Block h2: correction: block h11 (investigation results).Blocks d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0501 captures the reportable event of coil detachment.Impact code f23 captures the reportable event of unexpected medical intervention.Block h11: investigation results the product was not returned for analysis therefore technical analysis could not be performed; however, media analysis shows that the distal end of the coil is fractured.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 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.A risk review was completed and confirmed that the event of coil detachment of device or device component was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.With all the available information, boston scientific concludes that the reported event was confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Based on the investigation results, record review revealed no additional information related to the complaint.The results of record reviews did not provide evidence of a probable cause.This investigation was unable to determine a probable cause for the complaint event.Taking all available information into consideration an investigation conclusion code of cause not established was assigned to this investigation.

• 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: 24203052
• Report Number: 2124215-2026-05103
• Device Sequence Number: 14842360
• Product Code: FGO
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 03/18/2026; 04/22/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 04/10/2026; 05/12/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown