MAUDE Adverse Event Report: VOLCANO CORPORATION CRUX VENA CACA FILTER SYSTEM

Model Number 7024

Device Problems Activation, Positioning or Separation Problem (2906); Inadequate User Interface (2958)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2014

Event Type  malfunction  

Event Description

It was reported that the filter was positioned at -25 mm diameter/length 9.0 cm.When removing the deployment catheter, the tip of the inner sheath got caught on the webbing and pulled the filter down.The doctor tried to re-sheath but the same thing happened.The filter started to be pushed upward.They were able to bring it off the webbing but had to retrieve it because it was too low by the time they positioned it.The doctor was able to retrieve all of the filter.Another mfr's filter was used to successfully complete the procedure with no injury to the patient.

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 same failure mode within this lot.The device has not yet been returned to the mfr; however, a full eval will be conducted when the device is received and a supplemental report will be submitted when the investigation is completed.We will continue to monitor complaints for this failure mode via our standard complaint review process and data trending activities.

• Brand Name: CRUX VENA CACA FILTER SYSTEM
• 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 valley centre drive, ste 500; san diego, CA 92130 ; 8587204178
• MDR Report Key: 4030460
• MDR Text Key: 21175381
• Report Number: 2939520-2014-00062
• 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: 07/03/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: 7024
• Device Catalogue Number: 7024
• Device Lot Number: 0252 20005769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2014
• Initial Date FDA Received: 07/30/2014
• 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 Sequence Number: 1