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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 Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2020
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. The initial reporter's address is (b)(6). (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
Note: this report pertains to one of three devices used during the same procedure. Refer to manufacturer report # 3005099803-2020-05755, 3005099803-2020-05757 for the associated device information. It was reported to boston scientific corporation that a sensation large oval med stiff snare was to be used to treat a colorectal polyp in the colorectum during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2020. According to the complainant, during unpacking and outside the patient, the physician unpacked the device and the sterile bag was found broken and unusable. Reportedly, there were no other issues noted with the device. The procedure was then 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 Key10920652
MDR Text Key218917943
Report Number3005099803-2020-05759
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 12/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2020
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 Manufacturer12/02/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2020
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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