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U.S. Department of Health and Human Services

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

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VOLCANO CORPORATION CRUX VENA CACA FILTER SYSTEM Back to Search Results
Model Number 7024
Device Problems Activation, Positioning or SeparationProblem (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.

 
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Brand NameCRUX 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 Key4030460
MDR Text Key21175381
Report Number2939520-2014-00062
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 07/03/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/30/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2015
Device MODEL Number7024
Device Catalogue Number7024
Device LOT Number0252 20005769
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/03/2014
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

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