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

Model Number M0063303070

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2022

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has been received for analysis.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a gemini basket was to be used in the ureter during a stone removal procedure performed on an unknown date.During preparation, when the gemini basket was taken out of the package and was inspected, the sheath was found broken.A photo of the complaint device submitted by the customer showed the sheath was broken on the distal end.Another gemini basket was used to complete the procedure.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a gemini basket was to be used in the ureter during a stone removal procedure performed on an unknown date.During preparation, when the gemini basket was taken out of the package and was inspected, the sheath was found broken.A photo of the complaint device submitted by the customer showed the sheath was broken on the distal end.Another gemini basket was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: device code a0401 captures the reportable event of sheath break on distal end.Block h10: the returned mini gemini basket was analyzed, and a visual evaluation noted that the sheath and heat shrink are buckled accordion adjacent to the handle.However, is not possible to identify if the pouch was open.A functional inspection was performed and found the handle was actuated.After two attempts in trying to close the basket, the sheath was torn and the basket did not close.Under microscope magnification, the sheath was confirmed torn and buckled/accordion adjacent to the handle.The reported event was confirmed.Based on all available information, it is possible that operational factors such as handling/manipulation and excess of force applied could have caused the failures and consequently affect the performance of the device.However, the investigation is still incomplete to identify a conclusion for the failure sheath torn.Therefore, the most probable root cause is conclusion not yet available.The failure of heat shrink buckled/accordion could be due to excess of force applied during use and handling manipulation during preparation which consequently affect the device performance.Therefore, the most probable root cause for this failure 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
• Type of Device: 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: 14546641
• MDR Text Key: 293105424
• Report Number: 3005099803-2022-03020
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729074311
• UDI-Public: 08714729074311
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2024
• Device Model Number: M0063303070
• Device Catalogue Number: 330-307
• Device Lot Number: 0026588523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 06/08/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1