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

Model Number M0063302110

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

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 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
• 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: 10960176
• MDR Text Key: 226643187
• Report Number: 3005099803-2020-05933
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729069720
• UDI-Public: 08714729069720
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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: 66 YR