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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD INC. DENALI FEMORAL IVC FILTER FILTERM INTRAVASCULAR, CARDIOVASCULAR

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C.R. BARD INC. DENALI FEMORAL IVC FILTER FILTERM INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number DL900F
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802)
Event Date 01/09/2020
Event Type  Death  
Event Description
Pt expired due to cardiopulmonary arrest. One of the pins of the ivc filter embolized to the heart. Fda safety report id# (b)(4).
 
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Brand NameDENALI FEMORAL IVC FILTER
Type of DeviceFILTERM INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
C.R. BARD INC.
MDR Report Key9595842
MDR Text Key175370554
Report NumberMW5092261
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Catalogue NumberDL900F
Device Lot NumberGFDX0630
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/15/2020 Patient Sequence Number: 1
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