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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
Medical Device Problem Code Failure to Cut (2587)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/06/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
 
Event or Problem Description
It was reported to boston scientific corporation that a captivator lg oval thin wire flex snare was used during a colonoscopy procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the snare would not cut through the tissue as good as it used to.Reportedly, the snare was used for multiple polyps with unknown sizes.There were no other issues noted with this device.This device was used to complete the procedure.There were no patient complications reported as a result of this event.
 
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Brand Name
CAPTIVATOR
Common Device Name
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10343671
Report Number3005099803-2020-03021
Device Sequence Number811563
Product Code FDI
UDI-Device Identifier08714729019404
UDI-Public08714729019404
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K131700
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/30/2020
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
Operator of Device Health Professional
Device Expiration Date11/10/2022
Device Model NumberM00562391
Device Catalogue Number6239
Device Lot Number0024751037
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/07/2020
Initial Report FDA Received Date07/30/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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