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

Model Number	M0063301080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report health care facility: (b)(6).(b)(4).Visual inspection of the returned device found the working length does not present any issues, but the sheath was torn at the distal section.Functional test was performed and the device was able to open and close the basket successfully; therefore the customer complaint was not confirmed.Based on all available information, it is likely that operational factors such as handling and technique could contribute to the reported complaint, as the sheath could have become torn from either the attempts to open or close the basket or the interaction with another device.The returned unit did not show evidence of the reported event of the basket wire breaking however; therefore, it was concluded that the investigation conclusion code of this event will be documented as "no problem detected" since the reported device complaint or problem cannot be confirmed.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.
Event or Problem Description
It was reported to boston scientific corporation that a gemini stone retrieval basket was used in a ureterolithotomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the basket wire broke but is still attached to the basket at one end.The procedure was completed with another gemini basket.There were no patient complications as a result of this event.The patients condition at the conclusion of the procedure is reportedly stable.
Additional Manufacturer Narrative
Block h2: additional information: block e1 (initial reporter facility name, address 1, city, and zip/post code) block e1: initial report health care facility: (b)(6).Initial reporter address 1: (b)(6) initial reporter city: (b)(6) block h6: device code 1069 captures the reportable event of basket wire break.Block h10: visual inspection of the returned device found the working length does not present any issues, but the sheath was torn at the distal section.Functional test was performed and the device was able to open and close the basket successfully; therefore the customer complaint was not confirmed.Based on all available information, it is likely that operational factors such as handling and technique could contribute to the reported complaint, as the sheath could have become torn from either the attempts to open or close the basket or the interaction with another device.The returned unit did not show evidence of the reported event of the basket wire breaking however; therefore, it was concluded that the investigation conclusion code of this event will be documented as "no problem detected" since the reported device complaint or problem cannot be confirmed.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.
Event or Problem Description
It was reported to boston scientific corporation that a gemini stone retrieval basket was used in a ureterolithotomy procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the basket wire broke but is still attached to the basket at one end.The procedure was completed with another gemini basket.There were no patient complications as a result of this event.The patients condition at the conclusion of the procedure is reportedly stable.

• Brand Name: GEMINI
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10649972
• Report Number: 3005099803-2020-04384
• Device Sequence Number: 3604968
• Product Code: FFL
• UDI-Device Identifier: 08714729087410
• UDI-Public: 08714729087410
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2022
• Device Model Number: M0063301080
• Device Catalogue Number: 330-108
• Device Lot Number: 0024433996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 65