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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II; SNARE, FLEXIBLE

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BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II; SNARE, FLEXIBLE Back to Search Results
Model Number M00561241
Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a captivator round stiff snare was prepared for use during a procedure performed on (b)(6) 2023.During preparation when the device was tested, it was noted that there was an active cord connector connection problem.Upon inspection, the cautery pin was detached/broken.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Medical device code a0501 captures the reportable event of cautery pin detached.
 
Event Description
It was reported to boston scientific corporation that a captivator round stiff snare was prepared for use during a procedure performed on (b)(6) 2023.During preparation when the device was tested, it was noted that there was an active cord connector connection problem.Upon inspection, the cautery pin was detached/broken.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: medical device code a0501 captures the reportable event of cautery pin detached.Block h10 investigation results: a captivator round stiff snare was received for analysis.Visual and microscopic analysis of the returned device revealed that one measure of the 2 in 1 pin was out of specification.During the product analysis, the device was connected with three different cables.The bsi cable had connected well, the device was plugged with non-bsi active cord (conmed and erbe) and the cable also connected; however, no strong force was needed to remove it.Additionally, the 2-1 connector is correctly attached.No other problems were noted.The reported complaint of cautery pin detachment of device or device component could not be confirmed since the 2-1 connector was correctly attached.Based on the information available and the device analysis performed, it was noted that one dimension was not according to the 2 in 1 drawing, therefore, the most probable root cause for the reported complaint is manufacturing deficiency.Capa-00007233 was opened to investigate the issue between the interaction with 2 in 1 connector and the active cord, and issues reported in multiple devices.
 
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Brand Name
CAPTIVATOR II
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
propark, coyol
alajuela
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key16680836
MDR Text Key312751991
Report Number3005099803-2023-01661
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729855927
UDI-Public08714729855927
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K133987
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 05/05/2023
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 NumberM00561241
Device Catalogue Number6124
Device Lot Number0029939295
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/17/2023
Initial Date FDA Received04/05/2023
Supplement Dates Manufacturer Received04/18/2023
Supplement Dates FDA Received05/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2022
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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