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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 M0063303060
Device Problems Difficult to Open or Close (2921); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a gemini retrieval basket was used in the ureter during a rigid ureteroscopy procedure performed on an unknown date.During the procedure, when the gemini basket was taken out of the package and was inspected, the basket was found unable to open and the distal end of the sheath was detached.Another gemini basket was used to complete the procedure.There were no patient complications as a result of this event.
 
Manufacturer Narrative
Initial reporter name and address: (b)(6).The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 retrieval basket was used in the ureter during a rigid ureteroscopy procedure performed on an unknown date.During the procedure, when the gemini basket was taken out of the package and was inspected, the basket was found unable to open and the distal end of the sheath was detached.Another gemini basket was used to complete the procedure.There were no patient complications as a result of this event.
 
Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6).Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: device code a040609 captures the reportable event of sheath torn and detached.Block h10: the returned mini gemini basket was analyzed, and a visual evaluation noted that the basket was in a closed position.Under microscope magnification the sheath was buckled/accordion and torn adjacent to the handle.Additionally, due to the condition of the sheath the assessment could not be performed.The reported event that the sheath was torn near the basket was not confirmed.Based on all available information, it is possible that is excess of force applied during use could have caused these failures which consequently affect the performance of the device.The sheath torn, buckled accordion adjacent to the handle could have occurred due to the manipulation since the device did not work as expected.However, the investigation is still incomplete to identify the conclusion code for the (sheath torn).Since it is not an adequate evidence to confirm whether it is a manufacturing or design issue; therefore, the reported complaint will be documented as conclusion not yet available.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
 
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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
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 Key14193293
MDR Text Key289972362
Report Number3005099803-2022-02277
Device Sequence Number1
Product Code FFL
UDI-Device Identifier08714729074304
UDI-Public08714729074304
Combination Product (y/n)N
Reporter Country CodeFR
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 Physician
Type of Report Initial,Followup
Report Date 06/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0063303060
Device Catalogue Number330-306
Device Lot Number0027466983
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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