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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION CAPTIVATOR; SNARE, FLEXIBLE Back to Search Results
Model Number M00562451
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was prepared for use to remove polyps in the colon during an endoscopic colorectal polypectomy procedure performed on (b)(6) 2022.During preparation and outside the patient, the cautery pin was loose/disconnected.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: (product investigation) one captivator snare was received for analysis.Visual inspection of the returned device found no problems.The 2 in 1 connector did not have any problems.Microscopic test of the 2 in 1 connector found no damages.No other problems with the device were noted.The reported event of "cautery pin detached" could not be confirmed since no problems were noted with the 2 in 1 connector during visual and microscopic test.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.
 
Event Description
It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was prepared for use to remove polyps in the colon during an endoscopic colorectal polypectomy procedure performed on (b)(6) 2022.During preparation and outside the patient, the cautery pin was loose/disconnected.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
 
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Brand Name
CAPTIVATOR
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 Key15620690
MDR Text Key301919545
Report Number3005099803-2022-05957
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131700
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 12/20/2022
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 NumberM00562451
Device Catalogue Number6245
Device Lot Number0029411034
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/20/2022
Initial Date FDA Received10/17/2022
Supplement Dates Manufacturer Received12/06/2022
Supplement Dates FDA Received12/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2022
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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