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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 Mechanical Problem (1384); Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2021
Event Type  malfunction  
Manufacturer Narrative
This event was reported by the distributor.The reported physician and healthcare facility information are: (b)(6).(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon 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 10mm captivator ii round stiff snare was used to remove a polyp in the fundus of stomach during a polypectomy procedure performed on (b)(6) 2021.During the procedure and inside the patient, when the polypectomy device was released, it was found that it was not round enough to reach the round state of the picture on the outer package and it was not sharp enough to cut small polyps.Reportedly, the snare loop did not fully open before use and the snare did not fully open after it was removed from the scope/patient.There were no visible problems noted with the handle.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used to remove a polyp in the fundus of stomach during a polypectomy procedure performed on (b)(6) 2021.During the procedure and inside the patient, when the polypectomy device was released, it was found that it was not round enough to reach the round state of the picture on the outer package and it was not sharp enough to cut small polyps.Reportedly, the snare loop did not fully open before use and the snare did not fully open after it was removed from the scope/patient.There were no visible problems noted with the handle.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block e1: this event was reported by the distributor.The reported physician and healthcare facility information are: dr.(b)(6).Block h6: problem code a050702 captures the reportable event of polyp resecting problem.Block h10: (product investigation) one captivator snare was received for analysis.Visual analysis of the device did not note any problems.Functional evaluation of the returned device found that when the device was connected to the 10 inch loop fixture, it contracted and extended without problems.Continuity test was also performed and the device's electrical resistance was within specification, indicating a proper connection.The reported event of "loop failure to cut" could not be confirmed since the device cannot be functionally evaluated with respect to the anatomical/procedural factors encountered during the procedure.The reported event of "loop failure to extend" was not confirmed since the loop was contracted and extended during the function evaluation 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, functional, and continuity testing.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.This is selected as the most probable cause since the reported event could not be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
 
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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
MDR Report Key12570703
MDR Text Key274765654
Report Number3005099803-2021-05061
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729855903
UDI-Public08714729855903
Combination Product (y/n)N
PMA/PMN Number
K133987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2021
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 Number0027150488
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2021
Date Manufacturer Received10/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age56 YR
Patient Weight46
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