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

Model Number	M0063303040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
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 ureter during video laparoscopy procedure performed on (b)(6) 2022.During procedure, the basket wire broke when the basket was opened and closed.No patient complications were reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of basket wire break.Block h10: the returned gemini basket was analyzed, and a visual inspection observed that the device was received with the basket retracted or closed.The sheath was found buckled/accordion and torn at the proximal section.During functional inspection, the actuation of the handle found the basket was not able to open or close.No other issues were noted.The reported event of basket wire break was not confirmed.Based on all available information, the failure found sheath accordioned/buckled is likely related to device design.The axial force applied when the device is actuated can easily buckle the sheath.Additionally, if the device keeps being actuated, more buckling modes can be triggered, and eventually tore the sheath.Therefore, the most probable cause is cause traced to device design.A review of the manufacturing documentation for this reveled that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a gemini basket was used in the ureter during video laparoscopy procedure performed on (b)(6) 2022.During procedure, the basket wire broke when the basket was opened and closed.No patient complications were reported as a result of this event.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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15362333
• Report Number: 3005099803-2022-05093
• Device Sequence Number: 5206149
• Product Code: FFL
• UDI-Device Identifier: 08714729074281
• UDI-Public: 08714729074281
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/25/2023

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: 11/16/2024
• Device Model Number: M0063303040
• Device Catalogue Number: 330-304
• Device Lot Number: 0028402489
• 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: 08/16/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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 Age: 40 YR
• Patient Sex: Male