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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 Problem Inadequate User Interface (2958)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/24/2014
Event Type  Malfunction  
Event Description

It was reported that during an implant procedure, a crux vcf although fully deployed did not have complete apposition to the ivc wall due to the large diameter of the ivc. The first ivc diameter measurement was 20-21mm. After remeasuring the ivc diameter it was determined that the ivc diameter measured 30mm to 32mm. The measurement tool used during the procedure was a ruler that was placed on the pt abdomen. The physician stated that the ruler may have shifted causing an inaccurate measurement of the ivc. The crux vcf was successfully retrieved using a single 9f sheath and a gooseneck snare. The physician decided to implant a different type of ivc filter from a different mfr to accommodate the diameter of the pt's ivc.

 
Manufacturer Narrative

(b)(4). The crux vcf and delivery system was discarded and was not returned to the mfr for eval. The inaccurate measurement was likely due to the shifting of the ruler during the measurement of the ivc as reported by the physician. The crux vcf is only indicated for use for ivc diameters of 17-28mm. If the filter is placed in an ivc larger than 28mm, then there is the potential for filter migration to occur. Filter migration can be associated with severe adverse events. The physician was able to retrieved the crux vcf with no pt injury. A new ivc filter from a different mfr that can accommodate the diameter of the pt's ivc was successfully implanted. The mfg documentation for this device was reviewed and the device met all quality and mfg release criteria. To date, no other complaints have been reported for this failure mode within this lot. No further action is required.

 
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Brand NameCRUX VENA CAVA FILTER SYSTEM
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
VOLCANO CORPORATION
rancho cordova CA
Manufacturer (Section G)
VOLCANO CORPORATION
2870 kilgore rd.
rancho cordova CA 95670
Manufacturer Contact
denise stearns
3721 valaley centre dr
ste 500
san diego, CA 92130
8587204178
MDR Report Key3829623
MDR Text Key4498653
Report Number2939520-2014-00022
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/24/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2014
Device MODEL Number7025
Device Catalogue Number7025
Device LOT Number25301013
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/24/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/24/2014 Patient Sequence Number: 1
Treatment
9F INTRODUCER SHEATH; .035" BENTSON GUIDEWIRE
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