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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 Problems Sticking (1597); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2017
Event Type  malfunction  
Event Description
Snare was used for approximately 4-5 polypectomies. When attempting to advance snare on polyp 3, snare was bowing and getting caught and it was unable to momentarily advance.
 
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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 Key6659835
MDR Text Key78162570
Report Number6659835
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 06/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/12/2020
Device Model NumberM00562400
Device Catalogue NumberM0056240
Device Lot Number20158336
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/08/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer06/08/2017
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/22/2017 Patient Sequence Number: 1
Treatment
NO; NO OTHER THERAPIES
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