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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
Device Problem Positioning Failure (1158)
Patient Problem Injury (2348)
Event Date 08/30/2019
Event Type  Injury  
Event Description

In (b)(6)1998 the patient underwent placement of a greenfield vena cava filter. In (b)(6) 2019 a computed tomography (ct) scan revealed the filter appeared to be in a satisfactory position, however there was an additional filter which did not deploy; identified within the right iliac vein.

 
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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
480 pleasant street
watertown MA 02472
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9938839
MDR Text Key187199612
Report Number2134265-2020-04708
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK964284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/01/2001
Device MODEL Number43335
Device Catalogue Number43335
Device LOT Number0001266221
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
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: 04/08/2020 Patient Sequence Number: 1
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