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

Model Number	M0063303070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a gemini basket was to be used in the kidney on a stone retrieval procedure on (b)(6) 2022.According to the complainant, the gemini basket was unpacked and found the basket wire was broken.The procedure was cancelled and rescheduled on unknown date since there was no more basket available.There were no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a gemini basket was to be used in the kidney on a stone retrieval procedure on january 03, 2022.According to the complainant, the gemini basket was unpacked and found the basket wire was broken.The procedure was cancelled and rescheduled on unknown date since there was no more basket available.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Block h6: device problem code a0401 captures the reported event of basket wire broken.Block h10: the returned mini gemini was analyzed, and a visual evaluation noted that the basket wire was in a good shape.However, the sheath was found torn and buckled/accordion adjacent to the head shrink.Additionally, the working length was kinked at the middle section.No other issues with the device were noted.The reported event was not confirmed.Based on all available information, it is possible that operational factors such as manipulation and excess of force could cause the working length to kink at the middle section.Once the working length is kinked, it is possible that interaction with the scope and the repeating actuation of the handle cause the tear and buckled/accordion of the sheath.Therefore, the most probable root cause of the failure observed during analysis is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13369000
• Report Number: 3005099803-2022-00219
• Device Sequence Number: 19821552
• Product Code: FFL
• UDI-Device Identifier: 08714729074311
• UDI-Public: 08714729074311
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: 05/12/2024
• Device Model Number: M0063303070
• Device Catalogue Number: 330-307
• Device Lot Number: 0027302739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• 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