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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 Cut (2587)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and 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 was used during a polypectomy procedure performed on an unknown date.According to the complainant, during the procedure, the snare was unable to cut the polyp, both cold and hot.The procedure was completed with another captivator ii.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
 
Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: problem code 2587 captures the reportable event of failure to cut.Block h10: the returned captivator ii was analyzed, and a visual evaluation found no issues with the device and noted that the loop was within specification.In the functional evaluation, the device was connected to the 10 inch loop fixture, and the loop extended and contracted without issues.A continuity test was performed, and the device passed since the device's electrical resistance was within specification, indicating a proper connection.Additionally, the device also passed a dimensional inspection.No other issues with the device were noted.The reported event of loop failure to cut was not confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.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.Device analysis found no issues with the device during visual or functional testing.Based on the information available and the analysis of the returned device, the code selected as the most probable complaint cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
 
Event Description
It was reported to boston scientific corporation that a captivator ii was used during a polypectomy procedure performed on an unknown date.According to the complainant, during the procedure, the snare was unable to cut the polyp, both cold and hot.The procedure was completed with another captivator ii.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
 
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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 Key11149958
MDR Text Key226262823
Report Number3005099803-2020-06708
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 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/19/2023
Device Model NumberM00561221
Device Catalogue Number6122
Device Lot Number0026043591
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2021
Date Manufacturer Received01/26/2021
Patient Sequence Number1
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