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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Abdominal Pain (1685)
Date of Event 01/01/2014
Type of Reportable Event Serious Injury
Event or Problem Description
Medwatch number mw5090798.It was reported that patient experienced abdominal pain.On (b)(6) 2011, patient was implanted with a greenfield vena cava filter (gvcf).Per patient, she experienced severe abdominal pain 3 years post device implantation.Then 1 year later, patient developed gastrointestinal bleeding for which she was diagnosed with diverticulitis.About six months ago, the patient was diagnosed with acid reflux.The diagnosis came after experiencing a feeling of light headedness each time she went to the bathroom to have a bowel movement.The patient is currently on prilosec which seems to be helping with the feeling of discomfort and light headedness.
 
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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 Key9430998
Report Number2134265-2019-15006
Device Sequence Number16575384
Product Code DTK
UDI-Device Identifier08714729070276
UDI-Public08714729070276
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K964284
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/06/2019
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 Date06/30/2014
Device Model Number43335
Device Catalogue Number43335
Device Lot Number0014518070
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/20/2019
Initial Report FDA Received Date12/06/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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