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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 M00561231
Device Problem Failure to Cut (2587)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/30/2023
Event Type  malfunction  
Manufacturer Narrative
Block h6: imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf device code a050702 captures the reportable event of unable to cut.
 
Event Description
It was reported to boston scientific corporation that a 15mm captivator ii round stiff snare was used during a procedure performed on (b)(6) 2023.During the procedure, the snare encountered difficulties with cutting, resulting in a torn polyp which posed a risk of excessive bleeding and tearing.As a precaution, clips needed to be implanted.The bleeding was eventually stopped by the application of a hemostatic clip to the wound and the procedure was completed with the hemostatic clip.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf impact code f23 captures the reportable event of unexpected medical intervention; imdrf device code a050702 captures the reportable event of unable to cut.Block h10 investigation results: one captivator snare was received for analysis.Visual, functional and electrical analysis of the returned device found no device problems.No other problems were noted.The reported events of "loop failure to cut" could not be confirmed since could not be 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 was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Device analysis found no problems with the device during visual, functional and electrical test.Based on the analysis of the returned device and the information available, the code selected as the most probable root cause is no problem detected.This code was selected since the reported event could not be confirmed.Block b3 and block b5 have been updated based on additional information received on september 5, 2023.
 
Event Description
It was reported to boston scientific corporation that a 15mm captivator ii round stiff snare was used during a procedure performed on an unknown date.During the procedure, the snare encountered difficulties with cutting, resulting in a torn polyp which posed a risk of excessive bleeding and tearing.As a precaution, clips needed to be implanted.It was not reported what device was used to complete the procedure.It was not reported if there were no patient complications reported as a result of this event.According to additional information received on september 5, 2023, the event and procedure occurred on (b)(6) 2023, the torn polyp was located in the colon, the patient has no history of bleeding disorders, and was not on any anticoagulants.Also there were no perforation occurred and the event did not lead to prolonged hospitalization.The procedure was completed with a hemoclip.The patient is in stable condition and there were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf impact code f23 captures the reportable event of unexpected medical intervention imdrf device code a050702 captures the reportable event of unable to cut.Block h10 investigation results: one captivator snare was received for analysis.Visual, functional and electrical analysis of the returned device found no device problems.No other problems were noted.The reported events of "loop failure to cut" could not be confirmed since could not be 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 was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Device analysis found no problems with the device during visual, functional and electrical test.Based on the analysis of the returned device and the information available, the code selected as the most probable root cause is no problem detected.This code was selected since the reported event could not be confirmed.Block b3 and block b5 have been updated based on additional information received on september 5, 2023.Block h11: blocks b1, b2 and h1 have been corrected; changed the report type from serious injury report to malfunction report.Block h6 impact code has been corrected.
 
Event Description
It was reported to boston scientific corporation that a 15mm captivator ii round stiff snare was used during a procedure performed on an unknown date.During the procedure, the snare encountered difficulties with cutting, resulting in a torn polyp which posed a risk of excessive bleeding and tearing.As a precaution, clips needed to be implanted.It was not reported what device was used to complete the procedure.It was not reported if there were no patient complications reported as a result of this event.According to additional information received on september 5, 2023, the event and procedure occurred on (b)(6) 2023, the torn polyp was located in the colon, the patient has no history of bleeding disorders, and was not on any anticoagulants.Also there were no perforation occurred and the event did not lead to prolonged hospitalization.The procedure was completed with a hemoclip.The patient is in stable condition and there were no patient complications reported as a result of this event.
 
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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 Key17794758
MDR Text Key324003764
Report Number3005099803-2023-04847
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729855910
UDI-Public08714729855910
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K133987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00561231
Device Catalogue Number6123
Device Lot Number0030553984
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2022
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 Outcome(s) Required Intervention;
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