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

Model Number M0063301090

Device Problems Detachment of Device or Device Component (2907); Difficult to Open or Close (2921); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual analysis of the returned device found the sheath was torn at the distal end.The basket was found severely kinked at the distal section.Functional inspection found the basket failed to open when the handle was actuated.The unit was disassembled, and the cannula was found detached from the handle.Based on all available information, the failure of basket kinked and sheath torn at distal section could have been caused by handling and manipulation during the procedure, such as during attempts to collect the stone.The kink can then add tension force in the handle of the device, leading to the handle cannula to detach.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) product label.

Event Description

It was reported to boston scientific corporation that a gemini basket was used in the kidney during a rigid ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the gemini basket was very hard to open despite several maneuvers.The procedure time was extended as another gemini basket was used to complete the procedure.There were no patient complications as a result of this event.The investigation results revealed that the sheath was torn at the distal end; therefore, this is now an mdr reportable event.

• 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: 11030359
• MDR Text Key: 222627233
• Report Number: 3005099803-2020-06000
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729043355
• UDI-Public: 08714729043355
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2020

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: 06/01/2023
• Device Model Number: M0063301090
• Device Catalogue Number: 330-109
• Device Lot Number: 0025548934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 104