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

Model Number	M0063302110
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's weight is (b)(6) kg.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).Visual inspection of the returned device found the working length does not present any obvious kinks.However, the basket was detached from the device and the distal section of it was severely kinked.Functional analysis was unable to be performed due to the condition of the device.Based on all available information, it is most likely that handling and manipulation of the device during unpacking could have led to the basket section kinked.However, it remains unknown the most probable causes that contributed to the basket being broken.Since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event, the most probable cause of the basket being broken cannot be established due to the lack of evidence.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a device history record (dhr) review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
Event or Problem Description
It was reported to boston scientific corporation that a gemini basket was used in the left ureter during a cystoscopy, left retrograde, ureteroscopy, laser lithotripsy, stent insertion, and stone basket extraction procedure performed on (b)(6) 2020.According to the complainant, when the device was unpacked, the product was broken.The procedure was completed with another gemini basket.There were no patient complications reported as a result of this event.The patient's condition post-procedure was reported to be stable.The investigation results revealed that the basket was detached; therefore, this is now an mdr reportable event.

• 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: 10960176
• Report Number: 3005099803-2020-05933
• Device Sequence Number: 3189673
• Product Code: FFL
• UDI-Device Identifier: 08714729069720
• UDI-Public: 08714729069720
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2020

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 Model Number: M0063302110
• Device Catalogue Number: 330-211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR