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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 M00562301
Device Problem Failure to Cut (2587)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 10/09/2023
Event Type  Injury  
Manufacturer Narrative
Block e1: the reported health care facility is (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Imdrf patient code e2015 captures the reportable event of tissue damage.
 
Event Description
It was reported to boston scientific corporation that a captivator snare was used to remove a polyp around 0.8 cm in the ascending colon during a colonoscopy procedure performed on (b)(6), 2023.During the procedure, the polyp was not separated smoothly due to the large bluntness of the snare.The snare was securely attached to the active cord and no problems noted with the cautery pin.They made several cuts, and it successfully separated the polyp.However, the patient's wound area increased and caused a mucosal avulsion.Therefore, the physician used a hemostatic clip to close the wound.The procedure was completed with the original snare used.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block e1: (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Imdrf patient code e2015 captures the reportable event of tissue damage.Block h11: blocks a2 (age at time of event) has been updated based on corrected information received on february 7, 2024.
 
Event Description
It was reported to boston scientific corporation that a captivator snare was used to remove a polyp around 0.8 cm in the ascending colon during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the polyp was not separated smoothly due to the large bluntness of the snare.The snare was securely attached to the active cord and no problems noted with the cautery pin.They made several cuts, and it successfully separated the polyp.However, the patient's wound area increased and caused a mucosal avulsion.Therefore, the physician used a hemostatic clip to close the wound.The procedure was completed with the original snare used.There were no patient complications reported as a result of this event.
 
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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 Key18180550
MDR Text Key328613104
Report Number3005099803-2023-06174
Device Sequence Number1
Product Code FDI
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00562301
Device Catalogue Number6230
Device Lot Number0029153505
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/25/2023
Initial Date FDA Received11/21/2023
Supplement Dates Manufacturer Received02/07/2024
Supplement Dates FDA Received02/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2022
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;
Patient Age55 YR
Patient SexMale
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