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

Model Number 7025

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This case was reviewed and investigated according to volcano policy.Visual inspection was performed on the returned device.During the pre-decontamination inspection, it was observed there was an overall curvature to the delivery system.There was a kink in the inner shaft at 147mm from the distal tip as well as bunching at this location.There was also blood present on the outside of the inner shaft.All hub components were present.The adhesive between the luer knob and the handle body was broken and the luer knob was able to freely rotate.The delivery system was functional and the outer shaft was able to be retracted.The filter was no longer in the delivery system.Both the cw and ccw wireforms of the filter were intact.The caudal retrieval tail was slightly bent in the clockwise direction.No damage to the ptfe tubing was observed.All anchors were also present and no deformities were observed.All crimps, both plasma balls, and both marker bands were present and intact.The filter web was also intact.Efforts to gain additional information on the procedure were unsuccessful.The customer reported the filter would not deploy.Device analysis of the returned device found the filter was deployed upon receipt.Volcano found no evidence of malfunction or that the filter would have difficulty deploying.There was a slight bend to the caudal retrieval tail, but his was not significant enough to have any impact on deployment.The kink in the inner shaft could cause a filter to become stuck; however, from what was reported it appears the kink was caused during removal.As the filter was deployed upon receipt, we were unable to conclusively determine whether the filter was difficult to deploy or if it was a user issue.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.To date, no other complaints were reported for this same failure mode within this lot.We will continue to monitor these types of complaints.

Event Description

It was reported the interventional radiologist was trying to place an ivc filter and the filter would not deploy.When the delivery system was removed the catheter was kinked.The catheter and filter removed all intact.There was no harm to patient.All reasonably known patient information is included in this report.

• Brand Name: CRUX VENA CAVA FILTER SYSTEM, JUGULAR
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre dr ste 500; san diego CA 92130
• Manufacturer (Section G): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer Contact: tom brennan ; 3721 valley centre dr #500; san diego, CA 92130 ; 8587641320
• MDR Report Key: 5435684
• MDR Text Key: 38228687
• Report Number: 2939520-2016-00005
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 7025
• Device Catalogue Number: 400-0200.235
• Device Lot Number: 0253 20063674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2015
• 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
• Patient Age: 63 YR