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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 M00561223
Device Problem Failure to Deliver Energy (1211)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2024
Event Type  malfunction  
Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.
 
Event Description
It was reported to boston scientific corporation that a captivator ii snare was used in the colon to remove polyps during a colonoscopy-polypectomy procedure performed on an unknown date.During the procedure, there was no cautery.The cable was securely attached to the snare and the cable was changed out but there was no heat.There was no problem noted with the cautery pin.The snare was disengaged from the polyp and a non-bsc device was used to complete the procedure.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Block h10: investigation results: a captivator ii snare was received for analysis.Visual and microscopic inspection of the returned device revealed no problems had been noted.Electrical testing was performed, and the device was found within specification.No other problems were noted.The reported complaint of device failure to deliver energy was unable to be confirmed since the device passed electrical testing upon return.Upon product analysis, no problems were noted.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected since the reported complaint cannot be confirmed.
 
Event Description
It was reported to boston scientific corporation that a captivator ii snare was used in the colon to remove polyps during a colonoscopy-polypectomy procedure performed on an unknown date.During the procedure, there was no cautery.The cable was securely attached to the snare and the cable was changed out but there was no heat.There was no problem noted with the cautery pin.The snare was disengaged from the polyp and a non-bsc device was used to complete the procedure.There were no patient complications reported as a result of this event.
 
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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 DE COSTA RICA S.R.L.
2546 calle primera
propark, coyol
alajuela
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key18669467
MDR Text Key336189153
Report Number3005099803-2024-00301
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729861317
UDI-Public08714729861317
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/14/2024
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 NumberM00561223
Device Catalogue Number50297
Device Lot Number0031650026
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/16/2024
Initial Date FDA Received02/08/2024
Supplement Dates Manufacturer Received02/19/2024
Supplement Dates FDA Received03/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2023
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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