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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 M00562651
Device Problems Unsealed Device Packaging (1444); Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/16/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a sensation large oval med stiff snare was prepared for use in the intestinal tract during a polyp removal procedure performed on (b)(6) 2020. According to the complainant, during preparation and outside the patient, when the patient had enteroscopy on (b)(6) 2020 in (b)(6) hospital affiliated to (b)(6) university, the patient needed polyps removal. So the physician unpacked the device. There were five small packages inside, but the outer packaging on one of the devices was not well sealed. Additionally, there was a visible issue noted with the handle of the device according to the physician's description, however, the dealer could not get more details about it. Reportedly, the other four (4) small packages were not physically checked if the devices also have incomplete seal. The procedure was completed with another sensation snare. There were no patient complications reported as a result of this event. The patient condition following the procedure was reported to be stable.
 
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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 Key10992498
MDR Text Key220948701
Report Number3005099803-2020-05870
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K131700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00562651
Device Catalogue Number6265
Device Lot Number0024890051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2019
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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