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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 43175
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 04/09/1996
Event Type  Injury  
Event Description
On (b)(6) 1996, the patient underwent placement of a greenfield vena cava filter. On (b)(6) 2019, a computerized tomography (ct) scan revealed that one of the struts of the implanted greenfield filter had perforated through the anterior superior endplate of the l3 vertebral body and there was a fat plane between the limbs of the inferior vena cava (ivc) filter and the ivc wall suggesting perforation of the ivc wall.
 
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Brand NameGREENFIELD
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
model farm road
cork
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11748025
MDR Text Key248046387
Report Number2134265-2021-05348
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K901659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number43175
Device Catalogue Number43175
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/29/2021 Patient Sequence Number: 1
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