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

Model Number	M0063303060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2020
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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a gemini stone retrieval basket was used in a ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during preparation, the basket was broken when it was opened.The procedure was completed with another gemini basket.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a gemini stone retrieval basket was used in a ureteroscopy procedure performed on (b)(6), 2020.According to the complainant, during preparation, the basket was broken when it was opened.The procedure was completed with another gemini basket.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: problem code 1069 captures the reportable event of basket wire break.Block h10: visual analysis of the returned device found the basket was received in a closed/retracted position.The working length is free of obvious kinks and bends.Dimensional inspection found the device was within specifications.Functional inspection was performed and found the basket was able to extend and retract.Once the basket was extended, visual inspection found no broken wire and the basket was intact.Therefore, the most probable root cause is no problem detected since the 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.

• 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: 9785409
• Report Number: 3005099803-2020-00646
• Device Sequence Number: 714498
• Product Code: FFL
• UDI-Device Identifier: 08714729074304
• UDI-Public: 08714729074304
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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: 12/04/2022
• Device Model Number: M0063303060
• Device Catalogue Number: 330-306
• Device Lot Number: 0024877722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1