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

Model Number	M0063301090
Medical Device Problem Codes	Difficult to Open or Close (2921); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: date of event was approximated to 01/01/2026 based on the date the manufacturer became aware of the event.Block h6: device code a0414 captures the reportable event of sheath torn at distal end.
Event or Problem Description
It was reported that a 11mm gemini basket device was used during a procedure.Reportedly, it was noticed that the orange protective sheath split and the basket was unable to close.No further information was reported.
Event or Problem Description
It was reported that a 11mm gemini basket device was used during a procedure.Reportedly, it was noticed that the orange protective sheath split and the basket was unable to close.No further information was reported.
Additional Manufacturer Narrative
Block b3: date of event was approximated to 01/01/2026 based on the date the manufacturer became aware of the event.Block h6: device code a0414 captures the reportable event of sheath torn at distal end.Block h11: investigation results.The returned 11mm gemini basket device was analyzed, and a visual evaluation noted that the handle returned in good condition.It was also noted that the device returned with the basket on its open position.Microscopic examination was performed under magnification, and it was noticed that the sheath torn close to the basket.During functional inspection it was found that upon actuation of the handle, the basket was not able to be closed due to the torn material detected in the sheath.With the available information, boston scientific concludes that the reported event was confirmed.A review of device history record confirmed that this device met manufacturing specifications 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 sheath torn material and basket failure to close were defined in the risk documentation.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Based on the investigation results, this could be related to handling and manipulation of the device during procedure.It is probable that an excess of force applied to the device such as operational factors during their use could have led to sheath torn.Taking all available information into consideration, an investigation conclusion code of adverse event related to procedure was assigned to this investigation because the adverse event occurred during the procedure and the device had no influence on the 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: 24399917
• Report Number: 2124215-2026-09479
• Device Sequence Number: 15980875
• Product Code: FFL
• UDI-Device Identifier: 08714729043355
• UDI-Public: (01)08714729043355(17)280206(10)35794968
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: M0063301090
• Device Catalogue Number: 330-109
• Device Lot Number: 0035794968
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• 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