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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 M00561311
Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/01/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event was approximated to be (b)(6) 2019 as no event date was reported.(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a captivator large oval med stiff snare was used during a procedure performed on an unknown date.According to the complainant, during the procedure, it was noted that during the removal of a large polyp, the snare failed to coagulate.The scalpel generator and patch were replaced, however, the snare was unable to deliver energy.When attempting to retrieve the snare, the snare loop was stuck on the polyp and was unable to be removed.Reportedly, the snare was removed from the patient by cutting the polyp without cautery (cold) and a second captivator snare was used to complete cutting and coagulate in order to stop the bleeding.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.
 
Manufacturer Narrative
Block b3 (date of event): date of event was approximated to be may 01, 2019 as no event date was reported.Block h6: device problem code 1212 captures the reportable event of snare loop embedded in polyp.Block h10: investigation results: visual analysis of the returned device revealed that the device and cautery were in good condition.Electrical resistance test was performed and it measured 10.5 ohms, within manufacturing specification.Functional evaluation revealed that the device extends and retracts within specification.Based on the information available and the analysis performed, the most probable root 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.
 
Event Description
It was reported to boston scientific corporation that a captivator large oval med stiff snare was used during a procedure performed on an unknown date.According to the complainant, during the procedure, it was noted that during the removal of a large polyp, the snare failed to coagulate.The scalpel generator and patch were replaced, however, the snare was unable to deliver energy.When attempting to retrieve the snare, the snare loop was stuck on the polyp and was unable to be removed.Reportedly, the snare was removed from the patient by cutting the polyp without cautery (cold) and a second captivator snare was used to complete cutting and coagulate in order to stop the bleeding.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.
 
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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
MDR Report Key8680079
MDR Text Key147379036
Report Number3005099803-2019-02567
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729019251
UDI-Public08714729019251
Combination Product (y/n)N
PMA/PMN Number
K131700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/11/2021
Device Model NumberM00561311
Device Catalogue Number6131
Device Lot Number0022776289
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2019
Initial Date Manufacturer Received 05/15/2019
Initial Date FDA Received06/07/2019
Supplement Dates Manufacturer Received07/03/2019
Supplement Dates FDA Received07/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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