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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD IVC FILLER
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BARD IVC FILLER Back to Search Results
Model Number DL900J
Device Problems Collapse (1099); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2014
Event Type  Injury  
Event Description
Bard denal ivc filter placed (b)(6) 2014, product # dl900j, lot# gfxk0046.On (b)(6) 204 the filter was retrieved without difficulty.The ivc gram shows the filter in the center of the lumen and free of thrombus.Subsequently, an cook gunther-tulip retrieval system was employed, hook snared easily, upper portion of the filter collapsed with the retrieval set, backward tension was held on the device and it released.The device was brought into the inner sheath and an ivc gram was performed, normal.The filter was missing an upper leg and it appears within the ivc.Attempts were made to retrieve without success.A non-contrast ct was performed to evaluate the position and to attempt to document stability.The pt is to return in 5 days to evaluate for foreign body stability and migration.Future attempts at retrieval may be performed depending on the upcoming ct scan.
 
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Brand Name
IVC FILLER
Type of Device
IVC FILLER
Manufacturer (Section D)
BARD
tempe 85281
MDR Report Key4006271
MDR Text Key4687873
Report NumberMW5037716
Device Sequence Number1
Product Code DTK
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDL900J
Device Lot NumberGFXK0046
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
Patient Weight152
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