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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GEMINI; DISLODGER, STONE, BASKET, URETERAL, METAL
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BOSTON SCIENTIFIC CORPORATION GEMINI; DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063301060
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 02/23/2021
Event Type  Injury  
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 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.
 
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 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.
 
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Brand Name
GEMINI
Type of Device
DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11547748
MDR Text Key241929033
Report Number3005099803-2021-01164
Device Sequence Number1
Product Code FFL
UDI-Device Identifier08714729087403
UDI-Public08714729087403
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2023
Device Model NumberM0063301060
Device Catalogue Number330-106
Device Lot Number0025655228
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2021
Date Manufacturer Received03/30/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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