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

Model Number	M0063303060
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a gemini basket was used in the kidney during a kidney stone ureteroscopy procedure performed on (b)(6) 2022.During the procedure, a gemini basket was used in an attempt to remove kidney stones.However, when stone was captured and device was pulled back, the sheath at the distal end was torn and pull wire broke.The basket was opened and the stone was removed.The basket was removed from the patient.Another gemini basket was used to complete the procedure.There were no patient complications reported as a result of this event.
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.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (describe event or problem) block h6: device code a0401 captures the reportable event of pull wire break.Device code a0414 captures the reportable event of sheath torn material.Block h10: the returned gemini basket was received with the basket retracted or closed, and a visual inspection noted that the sheath was torn and accordion/buckled at the proximal section, and kinked at the distal end.Additionally, the pull wire was found kinked at the proximal end.During functional inspection, the actuation of handle found -the basket was not able to open or close.No other issues were noted.The reported event sheath torn at distal end was not confirmed.Based on all available information, the most likely cause is related to device design.The axial force applied when the device is actuated can easily buckle the sheath, causing the plastic deformation.Additionally, if the device keeps being actuated, more buckling modes can be triggered, and eventually tore the sheath.This failure can occur in the nominal, worst and best scenarios of the sheath and pull wire id and od dimensions.Therefore, the most probable root cause is cause traced to device design.The pull wire and sheath bent/kinked most likely happened due to excess force applied upon the handling of the device during the procedure.Therefore, cause code for the failure found is adverse event related to procedure.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 kidney during a kidney stone ureteroscopy procedure performed on (b)(6), 2022.During the procedure, a gemini basket was used in an attempt to remove kidney stones.However, when stone was captured and device was pulled back, the sheath at the distal end was torn and pull wire broke.The stone inside the basket was able to be released and the basket was removed from the patient.Another gemini basket was used to complete the procedure.There were no patient complications reported as a result of this event.***additional information received on august 11, 2022*** this event happened to two gemini baskets.The two gemini baskets were used on the same patient on the same procedure.Refer to report number 3005099803-2022-04550 for the other gemini basket.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (describe event or problem).Block h6: device code a0401 captures the reportable event of pull wire break.Device code a0414 captures the reportable event of sheath torn material.Block h10: 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 kidney during a kidney stone ureteroscopy procedure performed on (b)(6) 2022.During the procedure, a gemini basket was used in an attempt to remove kidney stones.However, when stone was captured and device was pulled back, the sheath at the distal end was torn and pull wire broke.The stone inside the basket was able to be released and the basket was removed from the patient.Another gemini basket was used to complete the procedure.There were no patient complications reported as a result of this event.***additional information received on august 11, 2022*** this event happened to two gemini baskets.The two gemini baskets were used on the same patient on the same procedure.Refer to report number 3005099803-2022-04550 for the other gemini basket.

• 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: 15217968
• Report Number: 3005099803-2022-04553
• Device Sequence Number: 6664139
• Product Code: FFL
• UDI-Device Identifier: 08714729074304
• UDI-Public: 08714729074304
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2022

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: 07/08/2024
• Device Model Number: M0063303060
• Device Catalogue Number: 330-306
• Device Lot Number: 0027635062
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 08/11/2022; 09/08/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 08/22/2022; 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• 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