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

Model Number	M0063301100
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was under the age of 18.Block h6: device code a0401 captures the reportable event of basket wire break.Block h11: investigation results.Upon evaluation of the available evidence of the device problem, it was observed that one of the basket wires was broken but was not fully detached.Additionally, it was also noted that the sheath was kinked at the distal section.The reported event of basket wire break was confirmed; however, the most probable cause of this issue cannot be established due to lack of evidence and without a proper evaluation of the device, it remains unknown the most probable causes that could have contributed to this event.
Event or Problem Description
It was reported that an 11mm gemini basket device was about to be used during a procedure.Reportedly, the device was damaged upon unpacking.Additionally, it was found that one of the wires was fractured and could not be used.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was under the age of 18.Block h6: device code a0401 captures the reportable event of basket wire break.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 closed position.It was also found that one of the basket wires was broken, and the sheath was kinked at the distal section.Microscopic examination was performed under magnification, and it was noticed that one of the basket wires was broken but not fully detached.Functional examination was performed, and the handle was actuated.The basket was able to open and close properly.With the available information, boston scientific concludes that the reported event was confirmed.Based on the investigation, this could be related to handling and manipulation of the device during preparation, it is probable that an excess of force applied to the device such as operational factors could lead to kink the sheath.Additionally, the ifu states that kinks in the sheath will hinder the mechanical operation of the basket.During the manufacturing, the device is inspected to confirm that the sheath is free of kinks by running fingers its length and if kinks are found the device is scrapped, actuation of the device to open position and confirmation that bend in basket wires extends from sheath, if bend is not outside of sheath the device is scrapped.This inspection ensures the integrity of the device and would have captured the encountered failures.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 an 11mm gemini basket device was about to be used during a procedure.Reportedly, the device was damaged upon unpacking.Additionally, it was found that one of the wires was fractured and could not be used.The procedure was completed with another of the same device with no patient complications.

• 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: 21786801
• Report Number: 2124215-2025-20244
• Device Sequence Number: 8692934
• Product Code: FFL
• UDI-Device Identifier: 08714729087427
• UDI-Public: (01)08714729087427(17)270724(10)34500595
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 05/07/2025

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: M0063301100
• Device Catalogue Number: 330-110
• Device Lot Number: 0034500595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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