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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 7024
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 the crux vcf deployment was successfully completed. Upon removing the delivery system, the physician tightened the hemostasis valve leaving the tracking tip extended per ifu. Upon pulling the delivery catheter out of the body, the edge of the tracking tip caught on the filter web causing the filter to move caudally with the delivery catheter removal. The result of this movement was that the filter was now positioned low in the ivc. It was reported that the caudal retrieval tail was now positioned at the confluence of the right iliac vein. The physician chose to retrieve the crux vcf because of the low positioning. The retrieval was completed successfully. The physician then deployed a second crux vcf. The filter was deployed in good position. The delivery catheter was removed from the body without incident. There was no surgical intervention required.

 
Manufacturer Narrative

(b)(4). 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. Review of volcano scientific affairs states that intervention in the act of removing the device was required by the clinician to mitigate potential pt harm. Placement of the device is a suboptimal position has the potential to cause pt harm. This risk is increased if the doctor does not retrieve or reposition the device. Vcf filters are typically placed just beneath the renal veins. Suprarenal placement has the potential to impair renal function. It is recommended that the tip of the filter be positioned at the level of the renal vein. The problem was identified and rectified by retrieving the filter. The second filter was successfully deployed. No pt injury was reported. The complaint device has arrived but has not been evaluated yet. A supplemental report will be submitted when the investigation is completed.

 
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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 Key3829633
MDR Text Key4447131
Report Number2939520-2014-00021
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
0 PatientS WERE 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 Number7024
Device Catalogue Number7024
Device LOT Number252 01016
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/10/2014
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/24/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/01/2013
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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