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

Model Number	M0063301040
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	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable investigation results of sheath torn on the distal end.Block h11: investigation results the returned 11mm gemini basket was analyzed, and a visual evaluation noted that the handle returned in good condition.It was also noted that the basket returned in open position.Microscopic examination was performed under magnification, and it was possible to notice a tear in the sheath which results the basket to exit the sheath before reaching the tip.Functional examination was performed with the handle actuated and the basket opened and close smoothly; however, the tear in the sheath was interfering the functionality of the device.With all the available information, boston scientific concludes that the reported event of was confirmed.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 lead to tear and through this tear in the sheath, the reported device malfunction may have occurred.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 transurethral bladder lithotripsy procedure.During the procedure, the basket could not open and close properly.The procedure was completed with another of the same device with no patient complications.Analysis of the returned device revealed a tear at the distal end of the sheath, which causes the basket to exit the sheath before reaching the tip.

• 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: 24169296
• Report Number: 2124215-2026-04346
• Device Sequence Number: 9000900
• Product Code: FFL
• UDI-Device Identifier: 08714729087397
• UDI-Public: (01)08714729087397(17)280402(10)36222566
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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: M0063301040
• Device Catalogue Number: 330-104
• Device Lot Number: 0036222566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• 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