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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 Problems Retraction Problem (1536); Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2021
Event Type  malfunction  
Manufacturer Narrative
The exact date of the event is unknown.The provided event date of (b)(6) 2021 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 captivator ii-10mm round stiff snare was used to remove a polyp in the colon during a polypectomy procedure performed on an unknown date.It was reported that during the procedure and inside the patient, snare would not cut properly.There was an attempt to apply cautery but the snare shape was not right when closed.The snare was securely attached to the active cord and no visible problems were noted with the cautery pin.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date of (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: problem code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results: a captivator ii-10mm round stiff snare was received for analysis.Visual inspection of the returned device revealed that no problems had been found.Functional inspection was performed and device contracted and extended well.Electrical test was performed and the device passed, indicating a proper connection.No other problems were noted.The reported complaint of loop failure to cut could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported complaint of loop retraction problem was not confirmed due to the loop contracted and extended without problems.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Device analysis found no problems with the device during visual and functional tests.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
Event Description
It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was used to remove a polyp in the colon during a polypectomy procedure performed on an unknown date.It was reported that during the procedure and inside the patient, snare would not cut properly.There was an attempt to apply cautery but the snare shape was not right when closed.The snare was securely attached to the active cord and no visible problems were noted with the cautery pin.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 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 Key12961530
MDR Text Key286010454
Report Number3005099803-2021-06356
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729855903
UDI-Public08714729855903
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
Type of Report Initial,Followup
Report Date 01/26/2022
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 Expiration Date06/30/2024
Device Model NumberM00561221
Device Catalogue Number6122
Device Lot Number0027598697
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/18/2021
Initial Date FDA Received12/08/2021
Supplement Dates Manufacturer Received01/04/2022
Supplement Dates FDA Received01/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2021
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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