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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION; SNARE, FLEXIBLE
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BOSTON SCIENTIFIC CORPORATION SENSATION; SNARE, FLEXIBLE Back to Search Results
Catalog Number M0056290
Device Problems Break (1069); Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2017
Event Type  malfunction  
Event Description
While physician was snaring a polyp off in the colon, the finger handles of the snare broke and slid out from the main body of the snare handle, not allowing the retraction of the wire into the snare sheath.After playing with the handle trying to hold it together, the wire was eventually retracted into the sheath and removed.Manufacturer response for snare, sensation short throw 13mm (per site reporter).Customer advocate specialist for boston scientific was notified.Arrangements made to return device and receive credit or replacement product.
 
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Brand Name
SENSATION
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key6604215
MDR Text Key76413596
Report Number6604215
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 Other
Type of Report Initial
Report Date 05/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberM0056290
Device Lot Number20214902
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/11/2017
Event Location Hospital
Date Report to Manufacturer05/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES; OLYMPUS COLONOSCOPE
Patient Age55 YR
Patient Weight127
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