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

Model Number	M0063301060
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
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 retrieval basket was used in the kidney during a ureteroscopy procedure performed on (b)(6) 2021.A piece of the gemini basket broke into the patients ureter.The broken piece was successfully recovered using a multi-use basket device.No patient complications have been reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of a piece of the gemini basket broke into the patients ureter.Block h10: visual inspection of the returned device found the sheath was broken at the distal end, and the basket wire was kinked.Therefore, the reported event of the basket wire detaching was not confirmed.Functional inspection was performed and found the basket was not able to close totally due to the broken sheath.No other issue was found.Based on all available information, it is likely that manipulation of the device during its use, the interaction with the scope or with other device, and/or anatomical/procedural factors during the procedure could have led to sheath breaking and the basket wire kinking.Once the basket wire is kinked, it could generate resistance during the handle actuation.Continued attempts to actuate the handle or force applied to the handle could result in the sheath breaking.Once the sheath is broken the device would become unable to extend or retract the basket properly.Therefore, the most probable root cause is adverse event related to the 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 or Problem Description
It was reported to boston scientific corporation that a gemini retrieval basket was used in the kidney during a ureteroscopy procedure performed on (b)(6) 2021.A piece of the gemini basket broke into the patients ureter.The broken piece was successfully recovered using a multi-use basket device.No patient complications have been reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 11547748
• Report Number: 3005099803-2021-01164
• Device Sequence Number: 3815035
• Product Code: FFL
• UDI-Device Identifier: 08714729087403
• UDI-Public: 08714729087403
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: M0063301060
• Device Catalogue Number: 330-106
• Device Lot Number: 0025655228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention