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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 10/31/2020
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 inspected on (b)(6) 2020. According to the complainant, upon inspection of the device, it was noted that the sterile packaging was not completely sealed. This event was not associated with a patient nor a procedure involved.
 
Event Description
It was reported to boston scientific corporation that a sensation large oval med stiff snare was inspected on (b)(6) 2020. According to the complainant, upon inspection of the device, it was noted that the sterile packaging was not completely sealed. This event was not associated with a patient nor a procedure involved.
 
Manufacturer Narrative
Block h6: problem code 1444 captures the reportable event of incomplete sterile packaging seal. Block h10: (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. The reported event was confirmed. Device analysis identified that the manufacturing seal of the pouch was 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.
 
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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
MDR Report Key10874695
Report Number3005099803-2020-05482
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729158110
UDI-Public08714729158110
Combination Product (y/n)N
PMA/PMN Number
K131700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/08/2022
Device Model NumberM00562651
Device Catalogue Number6265
Device Lot Number0024890051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
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