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

Model Number	M0063301090
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable investigation result of basket detached.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, however, the basket tip was kinked.Microscopic examination was performed under magnification, and it was noticed that the sheath was buckled, and the basket was detached from the pull wire.Functional examination was performed, and the basket was unable to close when the handle was actuated due to the detachment.Destructive test shows evidence of the torque mark.The device was disassembled, and the handle cannula was properly assembled to the pinch vise.The handle cannula with the pull wire was removed and it was possible to see that the basket was detached from the pull wire.With the available information, boston scientific concludes that the device returned with the basket detached from the pull wire, and the basket was unable to be closed.Additionally, the sheath was buckled, and the basket tip was kinked.Based on analysis results, the reported device performance allegation could be confirmed.The observed issues 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 cause the damages observed affecting the functionality of the device.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported that a 11mm gemini basket device was used during a ureteroscopy (urs) procedure.During the procedure, the handle was dysfunctional, and the device did not close.The procedure was completed with another of the same device and there were no patient complications reported as a result of this event.Analysis of the returned basket identified the basket was detached from the pull wire.

• 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: 21652385
• Report Number: 2124215-2025-16400
• Device Sequence Number: 7489537
• Product Code: FFL
• UDI-Device Identifier: 08714729043355
• UDI-Public: 08714729043355
• 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
• Report Date (Section B): 03/20/2025

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: M0063301090
• Device Catalogue Number: 330-109
• Device Lot Number: 0034036280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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