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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VOLCANO CORPORATION CRUX VENA CAVA FILTER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR

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VOLCANO CORPORATION CRUX VENA CAVA FILTER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 7025
Device Problems Activation, Positioning or SeparationProblem (2906); Inadequate User Interface (2958)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2014
Event Type  Malfunction  
Manufacturer Narrative

Internal reference: (b)(4). The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria. To date, no other complaints was reported for this same failure mode within this lot. The complaint device has not yet been returned to the manufacturer so a device evaluation has not been performed yet. At this time, we cannot conclusively determine the root cause of this reported failure. Therefore, this report is being submitted out of an abundance of caution. We will continue to monitor complaints for this failure mode via our standard complaint review process and dat trending activities.

 
Event Description

Tt was reported that the ivc was imaged and measurements were taken. The diameter was determined to be 27mm and the distance between the lowest renal vein and iliac vein bifurcation was 68mm. The filter was delivered via the right jugular vein. During deployment, it was observed that the filter was too low into the right iliac vein. However, the doctor continued the deployment and removed the delivery catheter. He repositioned the filter with a 2cm loop snare but the cranial retrieval tail was captured. Again, the doctor attempted to reposition the filter to its original location but the cranial tissue anchors became trapped into the snare catheter. At that point, it was decided t fully remove the crux filter. The filter was intact when removed and no patient injury was reported. Another filter from a different manufacturer was used.

 
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Brand NameCRUX VENA CAVA FILTER SYSTEM
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
VOLCANO CORPORATION
2870 kilgore rd.
rancho cordova CA 95670
Manufacturer (Section G)
VOLCANO CORPORATION
2870 kilgore rd.
rancho cordova CA 95670
Manufacturer Contact
denise stearns
3721 valley centre dr.
suite 500
san diego, CA 92130
8587204178
MDR Report Key3997756
MDR Text Key150873305
Report Number2939520-2014-00057
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK122585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/29/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/01/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2014
Device MODEL Number7025
Device Catalogue Number7025
Device LOT Number0253 20005765
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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