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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 M00561241
Device Problem Failure to Deliver Energy (1211)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/14/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a captivator ii-20mm round stiff snare was used in the rectum during a endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and inside the patient, the device was connected securely to the active cord but could not be electrified.No visible problem was noted with the cautery pin.There was no attempt to cold cut the polyp.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
 
Manufacturer Narrative
(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-20mm round stiff snare was used in the rectum during a endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and inside the patient, the device was connected securely to the active cord but could not be electrified.No visible problem was noted with the cautery pin.There was no attempt to cold cut the polyp.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
 
Manufacturer Narrative
Block h6: problem code (b)(6)captures the reportable event of device unable to deliver energy.Block h10: investigation results a captivator ii-20mm round stiff snare was received for analysis.Visual inspection of the returned device revealed no damages found on the snare and active cord.Dimensional test was performed and the 2 in 1 was compared with the go no go fixture (active cord gauge) and it was within of expect.Continuity and electrical test were performed and the device passed, indicating a proper connection.No other problems were noted.The reported complaint of device failure to deliver energy could not be confirmed since the device was found within specifications during electrical test and no damages were found.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected as the reported event of device failure to deliver energy could not be confirmed through product analysis.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
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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 Key14874716
MDR Text Key300337569
Report Number3005099803-2022-03457
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729855927
UDI-Public08714729855927
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K133987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00561241
Device Catalogue Number6124
Device Lot Number0027312018
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age50 YR
Patient Weight50 KG
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