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

Model Number	M0063303070
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 used in the proximal ureter during a ureteroscopy procedure performed on (b)(6) 2022.Prior to insertion, the gemini basket was inspected and found the basket would opened and closed.The gemini basket was then inserted and captured a stone.However, the basket failed to open to release the stone.The handle was dismantled and the basket cage was broken off to released the stone.A different device was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a051104 is being used to capture the reportable issue of basket failed to release stone.Block h10: the returned mini-gemini was analyzed, and a visual inspection found the device with the basket in closed position, and the sheath torn and buckled/accordion at the proximal section.For the functional test, the handle was actuated, and the basket was not able to open or close due to the found issues.The two pictures provided by the customer were analyzed.First picture show one "mini-gemini", out of its original pouch where the device is visible inside a plastic bag; however, no issue was observed.The other picture shows the pouch with the information which matches with the complaint information.The reported event of basket failure to release stone was confirmed.Based on all available information, it is most likely that when the device was actuated, the axial force over the device buckled the sheath, causing the plastic deformation.When the device keeps being actuated, more buckling modes can be triggered, and eventually torn the sheath.This failure can occur in the nominal, worst and best scenarios of the sheath.Therefore, the most probable cause is cause traced to device design.
Event or Problem Description
It was reported to boston scientific corporation that a gemini basket was used in the proximal ureter during a ureteroscopy procedure performed on (b)(6) 2022.Prior to insertion, the gemini basket was inspected and found the basket would opened and closed.The gemini basket was then inserted and captured a stone.However, the basket failed to open to release the stone.The handle was dismantled and the basket cage was broken off to released the stone.A different device was used to complete the procedure.There were no patient complications reported as a result of this 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15191312
• Report Number: 3005099803-2022-04465
• Device Sequence Number: 5566301
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2024
• Device Model Number: M0063303070
• Device Catalogue Number: 330-307
• Device Lot Number: 0027144975
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown