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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW SNARE, FLEXIBLE

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BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW SNARE, FLEXIBLE Back to Search Results
Model Number M00562673
Device Problems Electrical /Electronic Property Problem (1198); Entrapment of Device (1212); Failure to Cut (2587)
Patient Problem Tissue Damage (2104)
Event Date 09/02/2020
Event Type  malfunction  
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 Description
It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2020. According to the complainant, during the procedure, the snare had issues cutting through the tissue both hot and cold. When using cold polypectomy, it would not cut cleanly through the tissue smoothly which caused chewing like feeling when trying to close the snare loop to resect the one (1) cm target polyp. There were no treatment provided for the tissue "chewing" experienced by the patient. When the device was used with cautery, it seemed that the current flow was not as smooth as usual and it made it more difficult to cut through the target polyps. Reportedly, the electrical current transmitted was noticed to be less than normal. The snare was securely attached to the active cord and there were no visible issues noted with the cautery pins. An endostat generator was used, however, the settings of the generator was not reported. The physician troubleshoot the device by opening and closing the snare. The connection and cautery settings were also double checked. However, the issue was not resolved. The procedure was then completed with a different device. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure is reported to be stable and fine.
 
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Brand NameSENSATION SHORT THROW
Type of DeviceSNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC 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 Key10586853
MDR Text Key208552522
Report Number3005099803-2020-04138
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
Type of Report Initial
Report Date 09/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00562673
Device Catalogue Number6267-40
Device Lot Number0025677105
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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