MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Gemini; dislodger, stone, basket, ureteral, metal

Model Number	M0063301080
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a gemini basket was used during a rigid laser ureterorenolithotripsy (ursl) procedure.During the procedure, the basket jammed during opening and closing attempts.However, when they try opening it again the basket broke near the junction and it was impossible to retrieve the basket.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of basket wire broken.

• 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: 50196997
• Report Number: 2124215-2026-42676
• Device Sequence Number: 10274783
• Product Code: FFL
• UDI-Device Identifier: 08714729087410
• UDI-Public: (01)08714729087410(17)281006(10)37640817
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: M0063301080
• Device Catalogue Number: 330-108
• Device Lot Number: 0037640817
• 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: 07/16/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 10/07/2025
• 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: Female