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

Model Number	M0063303060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of basket wire break.This is for the same event as manufacturer reports 2124215-2024-47052 and 2124215-2024-47055.
Event or Problem Description
It was reported that three gemini baskets were used during the same procedure, and the baskets wires broke either before the procedure or after use.Boston scientific has been unable to obtain additional information regarding the procedure and patient outcome to date, despite good faith efforts.This report is for the first of the three devices.

• 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: 19924753
• Report Number: 2124215-2024-47049
• Device Sequence Number: 2781833
• Product Code: FFL
• UDI-Device Identifier: 08714729074304
• UDI-Public: 08714729074304
• 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): 08/06/2024

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: M0063303060
• Device Catalogue Number: 330-306
• Device Lot Number: 0033731838
• 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: 07/12/2024
• Initial Report FDA Received Date: 08/06/2024
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown