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

Model Number	M0063301080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of basket wire break.
Event or Problem Description
It was reported to boston scientific corporation that a gemini basket retrieval was used in the kidney during endoscopic basket lithotomy procedure performed on (b)(6) 2023.During the procedure, when the basket captured the stone, the basket wire was fractured; however, the basket wire did not completely detach from the basket.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a gemini basket retrieval was used in the kidney during endoscopic basket lithotomy procedure performed on (b)(4) 2023.During the procedure, when the basket captured the stone, the basket wire was fractured; however, the basket wire did not completely detach from the basket.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of basket wire break.Block h10: investigation results: the returned 11mm gemini basket was analyzed, and a visual evaluation noted that one basket wire was broken.Functional examination was performed, and the handle was actuated.Additionally, the basket was able to open and close.Microscopic examination was performed, and it was noticed that one basket wire was broken and not fully detached.With all the available information, boston scientific concludes that the reported event of basket wire break 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 break the basket wire.The device meets all manufacturing specifications required and passed all the controls and inspections; no abnormalities were reported during the assembly process.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.

• 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: 18261502
• Report Number: 2124215-2023-68383
• Device Sequence Number: 7690887
• Product Code: FFL
• UDI-Device Identifier: 08714729087410
• UDI-Public: 08714729087410
• 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): 01/29/2024

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 Expiration Date: 06/14/2026
• Device Model Number: M0063301080
• Device Catalogue Number: 330-108
• Device Lot Number: 0031824614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 65 KG