• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION GEMINI; DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063303070
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address: (b)(6).(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 medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a gemini basket was to be used in the kidney on a stone retrieval procedure on (b)(6) 2022.According to the complainant, the gemini basket was unpacked and found the basket wire was broken.The procedure was cancelled and rescheduled on unknown date since there was no more basket available.There were no patient complications as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a gemini basket was to be used in the kidney on a stone retrieval procedure on january 03, 2022.According to the complainant, the gemini basket was unpacked and found the basket wire was broken.The procedure was cancelled and rescheduled on unknown date since there was no more basket available.There were no patient complications as a result of this event.
 
Manufacturer Narrative
E1: initial reporter address: (b)(6).Block h6: device problem code a0401 captures the reported event of basket wire broken.Block h10: the returned mini gemini was analyzed, and a visual evaluation noted that the basket wire was in a good shape.However, the sheath was found torn and buckled/accordion adjacent to the head shrink.Additionally, the working length was kinked at the middle section.No other issues with the device were noted.The reported event was not confirmed.Based on all available information, it is possible that operational factors such as manipulation and excess of force could cause the working length to kink at the middle section.Once the working length is kinked, it is possible that interaction with the scope and the repeating actuation of the handle cause the tear and buckled/accordion of the sheath.Therefore, the most probable root cause of the failure observed during analysis is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13369000
MDR Text Key288877427
Report Number3005099803-2022-00219
Device Sequence Number1
Product Code FFL
UDI-Device Identifier08714729074311
UDI-Public08714729074311
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0063303070
Device Catalogue Number330-307
Device Lot Number0027302739
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received04/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-