Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENFIELD; FILTER, INTRAVASCULAR, CARDIOVASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION GREENFIELD; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 43335
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Perforation (2001)
Date of Event 12/04/2019
Type of Reportable Event Serious Injury
Event or Problem Description
On (b)(6) 2009 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan revealed extraluminal extension of the strut along the posterior aspect measuring 4mm.No fracture of the filter or strut was noted.
 
Event or Problem Description
On (b)(6) 2009 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan revealed extraluminal extension of the strut along the posterior aspect measuring 4mm.No fracture of the filter or strut was noted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GREENFIELD
Common Device Name
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9949028
Report Number2134265-2020-04790
Device Sequence Number3296551
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 Year2009
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/13/2020
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? No
Operator of Device Health Professional
Device Expiration Date12/31/2011
Device Model Number43335
Device Catalogue Number43335
Device Lot Number0012348508
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/24/2020
Supplement Date Received by Manufacturer07/29/2020
Initial Report FDA Received Date04/10/2020
Supplement Report FDA Received Date08/13/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age77 YR
-
-