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 43175
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
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) 2003 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan of the abdomen revealed positive mesenteric perforation.There were no signs of tilting, migration, stenosis, and fracture/bending.
 
Event or Problem Description
On (b)(6)2003 the patient underwent placement of a greenfield vena cava filter.On (b)(6)2019, a computed tomography (ct) scan of the abdomen revealed positive mesenteric perforation.There were no signs of tilting, migration, stenosis, and fracture/bending.
 
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 Key9949031
Report Number2134265-2020-04760
Device Sequence Number3296552
Product Code DTK
UDI-Device Identifier08714729114666
UDI-Public08714729114666
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K901659
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2003
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/21/2020
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 Date11/01/2005
Device Model Number43175
Device Catalogue Number43175
Device Lot Number0005189514
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 Date08/21/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age72 YR
-
-