MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GEMINI; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063303060
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire break.
Event or Problem Description
It was reported that a gemini was used during a ureteroscopy with laser lithotripsy procedure.Prior to procedure, it was found that the device failed to open or close after opening out of the box.It appears that the wire at the right handle of the device was damaged.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire break.Block h11: the mini-gemini device was not returned for analysis.However, the customer provided a picture of the device.During media inspection, the image showed one mini-gemini with the black heat shrink buckled and the sheath kinked.Based on the available evidence, these conditions could be related to handling or manipulation of the device during preparation or use.It is probable that the application of excessive force or operational factors during the procedure could lead to deformation such as sheath kinking and heat shrink buckling.A review of the device history record (dhr) indicated that the device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the events of "pull wire break", "basket failure to open", "basket failure to close", sheath bent/kinked" and "system damaged (black heat shrink buckled)" were defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since it occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported that a gemini was used during a ureteroscopy with laser lithotripsy procedure.Prior to procedure, it was found that the device failed to open or close after opening out of the box.It appears that the wire at the right handle of the device was damaged.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• Brand Name: GEMINI
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24525088
• Report Number: 2124215-2026-12452
• Device Sequence Number: 18573022
• Product Code: FFL
• UDI-Device Identifier: 08714729074304
• UDI-Public: (01)08714729074304(17)280826(10)37313394
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: M0063303060
• Device Catalogue Number: M0063303060
• Device Lot Number: 0037313394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 08/27/2025
• 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