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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR; SNARE, FLEXIBLE
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BOSTON SCIENTIFIC CORPORATION CAPTIVATOR; SNARE, FLEXIBLE Back to Search Results
Model Number M00562391
Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a captivator lg oval thin wire flex snare was used to remove intestinal polyps in the intestinal tract during a polypectomy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the device was securely attached to the active cord but there was no response to electric cutting.No visible problem was noted with the cautery pin.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of 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.
 
Manufacturer Narrative
Block h6: medical device code a090402 captures the reportable event of could not deliver energy medical device code a050702 captures the reportable event of polyp resecting problems.Block h10: (product investigation) one captivator snare was received for analysis.Visual analysis of the device noted that no damages were found.The active cord was carefully inspected and no damages were found.Dimensional test was performed, the 2 in 1 was compared with the go no go fixture (active cord gauge) and it was within of expect.Electrical test was also performed and the device passed, indicating a proper connection.No other problems were noted.The reported event of "device failure to deliver energy" could not be confirmed since no problems were noted with the electrical device testing during continuity test upon return.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.Device analysis found no problems with the device during visual and continuity test.Based on the analysis of the returned device and the information available, the code selected as the most probable cause 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 at the time of release for distribution.
 
Event Description
It was reported to boston scientific corporation that a captivator lg oval thin wire flex snare was used to remove intestinal polyps in the intestinal tract during a polypectomy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the device was securely attached to the active cord but there was no response to electric cutting.No visible problem was noted with the cautery pin.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
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Brand Name
CAPTIVATOR
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 Key14876142
MDR Text Key301125410
Report Number3005099803-2022-03452
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729019404
UDI-Public08714729019404
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K131700
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 09/16/2022
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 Expiration Date11/10/2022
Device Model NumberM00562391
Device Catalogue Number6239
Device Lot Number0024751037
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2019
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 Age72 YR
Patient SexFemale
Patient Weight55 KG
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