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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIFLEX SNARE, FLEXIBLE

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BOSTON SCIENTIFIC CORPORATION CAPTIFLEX SNARE, FLEXIBLE Back to Search Results
Model Number M00562400
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Blood Loss (2597)
Event Date 09/15/2017
Event Type  malfunction  
Event Description
Cautery snare placed around patient bronchial tumor, foot pedal stepped on, but cautery wouldn't work. Replaced everything in the cautery loop and still wouldn't work. Finally got the snare off the tumor and replaced snare, and the replacement snare worked. Small amount of unneeded bleeding occurred because of snare malfunction and extended stress placed on tumor while not being cauterized.
 
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Brand NameCAPTIFLEX
Type of DeviceSNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752
MDR Report Key6893179
MDR Text Key87350267
Report Number6893179
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/18/2017,09/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/21/2019
Device Model NumberM00562400
Device Lot Number18945550
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/18/2017
Event Location Hospital
Date Report to Manufacturer09/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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