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

Model Number	M0063303040
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	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2023 based on the date the manufacturer became aware of the event.Block h6: device code a0401 captures the reportable investigation result of basket wire break.Block h10: investigation result: the returned mini gemini basket was analyzed, and a visual evaluation noted that the sheath was bent at the proximal section and the basket was overextended at the distal section.Microscopic examination was performed, and the sheath was buckled/accordioned at the proximal section and the basket wires were broken and not fully detached.Functional examination was performed, and the handle was actuated.Additionally, the basket was able to open and close.With all the available information, boston scientific concludes that the reported event of basket failure to close was not confirmed.The investigation found that the sheath is bent/kinked, and the basket wires are broken.These 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 bend/kinked the sheath consequently causing the over extension of the basket.On the other hand, the same excess of force applied to the device could cause the breaks of the basket wires.Additionally, the sheath was found buckled/accordioned.When the device was actuated the axial force over the device can easily buckle the sheath, causing the plastic deformation, and, if the device keeps being actuated, more buckling modes can be triggered.This failure can occur in the nominal, worst and best scenarios of the sheath and pull wire inner diameter and outer diameter dimensions.Based on the investigation results, the most probable root cause of cause traced to device design was assigned to this investigation.
Event or Problem Description
It was reported to boston scientific corporation that a mini gemini retrieval basket was used during a procedure performed on an unknown date.During the procedure, the device stop closing; however, after cleansing, it started working properly again.No patient complications have reported as a result of this event.This event has been deemed a reportable event based on the investigation findings that the basket wires are broken.Please see block h10 for full investigation details.No further information has been obtained despite good faith efforts.

• 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: 18379324
• Report Number: 3005099803-2023-06834
• Device Sequence Number: 18042588
• Product Code: FFL
• UDI-Device Identifier: 08714729074281
• UDI-Public: 08714729074281
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2023

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 Expiration Date: 03/26/2026
• Device Model Number: M0063303040
• Device Catalogue Number: 330-304
• Device Lot Number: 0031315073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown