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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENFIELD; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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BOSTON SCIENTIFIC CORPORATION GREENFIELD; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 43335
Medical Device Problem Code Positioning Problem (3009)
Health Effect - Clinical Code Perforation (2001)
Date of Event 02/25/2019
Type of Reportable Event Serious Injury
Event or Problem Description
On (b)(6) 2007 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a positive computed tomography (ct) scan revealed a slight tilt of the filter to the left and a mesenteric perforation.
 
Event or Problem Description
On (b)(6) 2007 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a positive computed tomography (ct) scan revealed a slight tilt of the filter to the left and a mesenteric perforation.
 
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Brand Name
GREENFIELD
Common Device Name
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9943565
Report Number2134265-2020-04648
Device Sequence Number18999284
Product Code DTK
UDI-Device Identifier08714729124993
UDI-Public08714729124993
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K955396
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/31/2009
Device Model Number43335
Device Catalogue Number43335
Device Lot Number0009018220
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/24/2020
Supplement Date Received by Manufacturer08/06/2020
Initial Report FDA Received Date04/09/2020
Supplement Report FDA Received Date08/27/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age64 YR
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