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

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.

• Brand Name: CRUX VENA CAVA FILTER SYSTEM
• Type of Device: FILTER, 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 Key: 3829633
• MDR Text Key: 4447131
• Report Number: 2939520-2014-00021
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: 7024
• Device Catalogue Number: 7024
• Device Lot Number: 252 01016
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2014
• Initial Date FDA Received: 03/24/2014
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1