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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENFIELD IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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BOSTON SCIENTIFIC CORPORATION GREENFIELD IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number UNKNOWN
Device Problem Material Erosion (1214)
Patient Problems Pain (1994); Ulceration (2116)
Event Date 10/14/2014
Event Type  malfunction  
Event Description
Patient underwent explantation of a caval filter via laparotomy with cavotomy for chronic pain and duodenal ulceration secondary to caval filter erosion into the duodenum, retroperitoneum and aorta.
 
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Brand NameGREENFIELD IVC FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key5376052
MDR Text Key36236498
Report Number5376052
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/16/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/16/2015
Event Location Hospital
Date Report to Manufacturer11/16/2015
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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