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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); Retraction Problem (1536); Failure to Cut (2587); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/07/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure 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 treat colorectal polyps during a cold polypectomy procedure in the colon performed on (b)(6) 2021.During the procedure, when they tried to remove the target polyp, it could not be removed.When the device was removed from the endoscope, it was noted that the sheath was twisted and could not be opened or closed.The procedure was completed with another captivator snare.There were no patient complications nor any patient injury reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a captivator ii 10mm round stiff snare was used to treat colorectal polyps during a cold polypectomy procedure in the colon performed on (b)(6) 2021.During the procedure, when they tried to remove the target polyp, it could not be removed.When the device was removed from the endoscope, it was noted that the sheath was twisted and could not be opened or closed.The procedure was completed with another captivator snare.There were no patient complications nor any patient injury reported as a result of this event.
 
Manufacturer Narrative
Block h6: problem code a050702 captures the reportable event of loop difficulty resecting polyp.Block h10: (product investigation) one captivator snare was received for analysis.Visual inspection of the returned device revealed that the working length was detached and has evidence of flare noted.A continuity test was performed and the device passed since the device's electrical resistance was within specification, indicating a proper connection.The reported events of "loop failure to extend," "loop retraction problem" and "working length bent" were confirmed.The reported issue of "loop failure to cut " could not be confirmed since the devices cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.Additionally, the device pass the continuity test upon return.This investigation is assigned a conclusion code of "adverse event related to procedure." this is defined as the adverse event occurred during the procedure and the device had no influence on the event.This code was selected as the most probable complaint cause based on the information available.The product record review confirmed that this is not a new failure type and the risk is anticipated.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Upon product analysis it was observed that the working length was detached.Evidence of flare was noted on the catheter which showed that the process was done in the unit and that ensures that the components were attached.These types of failures could get damage during its manipulation.Most likely procedural factors as handling of the device, the technique used by the physician during initial use, setup, power up, or shortly thereafter could have affected its performance and its intended purpose, leading to the reported event.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 Key11904055
MDR Text Key254592762
Report Number3005099803-2021-02468
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 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/09/2023
Device Model NumberM00561221
Device Catalogue Number6122
Device Lot Number0026472037
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2021
Date Manufacturer Received06/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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