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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); Electric Shock (2554)
Event Date 02/26/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a captivator small oval stiff snare was used during a colonoscopy with polypectomy procedure performed on (b)(6) 2020. According to the complainant, during the procedure, the technician was shocked by the handle of the snare. Reportedly, the technician was wearing regular gloves. An olympus generator was used with unknown settings and the technician was sent to the emergency room for surveillance. The procedure was completed with this 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 fine.
 
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Brand NameCAPTIVATOR
Type of DeviceSNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENIFIC 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 Key9849766
MDR Text Key188830456
Report Number3005099803-2020-01190
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberM00562301
Device Catalogue Number6230
Device Lot Number0024154997
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/18/2020 Patient Sequence Number: 1
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