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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 M00561221
Device Problem Failure to Deliver Energy (1211)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was used in the colon during a polypectomy procedure performed on an unknown date.During the procedure and inside the patient, the device was connected for cautery to perform polypectomy however no energy was generated to perform the procedure.The snare was securely attached to the active cord and there were no abnormalities observed on the ablation pin.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.Problem code (b)(4) captures the reportable event of snare unable to deliver energy.
 
Event Description
It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was used in the colon during a polypectomy procedure performed on an unknown date.During the procedure and inside the patient, the device was connected for cautery to perform polypectomy however no energy was generated to perform the procedure.The snare was securely attached to the active cord and there were no abnormalities observed on the ablation pin.The procedure was completed with another of the same device.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: problem code a090402 captures the reportable event of snare unable to deliver energy.Block h10: investigation results a captivator ii round stiff snare was received for analysis.Visual inspection of the returned device revealed that no damages were found.Also the active cord revealed that no damages were found.Functional testing was performed, and the loop could extend and retract well.Dimensional testing revealed that it was within of expect.Electrical testing was performed, and the device was found within specification.No other problems were noted.The reported event of failed to deliver energy could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure and device passed the electrical test.During visual evaluation of the returned device, it was revealed that no damages were found.Also the active cord revealed that no damages were found.No other issues with the device were noted.The product record review confirmed that this is not a new failure type and the risk is anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.
 
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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 Key15668704
MDR Text Key306811959
Report Number3005099803-2022-06301
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729855903
UDI-Public08714729855903
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 12/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00561221
Device Catalogue Number6122
Device Lot Number0029153517
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/05/2022
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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