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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD BARD DENALI IVC FILTER

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BARD BARD DENALI IVC FILTER Back to Search Results
Catalog Number DL900F
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Atrial Fibrillation (1729); Impaired Healing (2378)
Event Date 03/21/2019
Event Type  Injury  
Event Description

Tine broke off of ivc filter during removal and traveled to a small vessel within the pulmonary artery.

 
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Brand NameBARD
Type of DeviceDENALI IVC FILTER
Manufacturer (Section D)
BARD
1625 w 3rd st
tempe AZ 85281
MDR Report Key8491979
MDR Text Key141257473
Report Number8491979
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 03/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2019
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2021
Device Catalogue NumberDL900F
Device LOT NumberGFCU1991
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/28/2019
Distributor Facility Aware Date03/21/2019
Device Age3 mo
Event Location Hospital
Date Report TO Manufacturer03/28/2019
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: 04/01/2019 Patient Sequence Number: 1
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