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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 Patient Involvement (2645)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6). (b)(4). (product investigation). The returned sensation large oval med stiff snare was analyzed and a visual evaluation noted that the manufacturing seal of the pouch was incomplete. No specific failure was reported against the device. Therefore, no assessment on the confirmation of the complaint can be made. However, the product analysis revealed that the device had the packaging seal incomplete. It is important to mention that this event was not associated with a patient nor a procedure involved. An investigation was opened to further investigate the most probable cause for this issue but since the investigation is still in progress, the investigation conclusion code selected for this complaint is cause not established. A review of the device history record (dhr) was performed and confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
 
Event Description
It was reported to boston scientific corporation that a sensation large oval med stiff snare was returned for evaluation on (b)(6) 2020. According to the complainant, a sensation large oval med stiff snare was unpacked on (b)(6) 2020 in (b)(6) of (b)(6) hospital affiliated to (b)(6) university. There were five small packages inside, but the outer packaging on one of the devices was not well sealed. Reportedly, the other four (4) small packages were not physically checked if the devices also have incomplete seal. This event was not associated with a patient nor a procedure involved.
 
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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 Key11109473
MDR Text Key225340890
Report Number3005099803-2020-06513
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
Report Date 01/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2021
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 Manufacturer12/14/2020
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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