FDA Adverse Event Malfunction Summary report: N

CRUX VENA CAVA FILTER SYSTEM-FEMORAL

MDR report key: 3871678 · Received April 16, 2014

Report

Report Number: 2939520-2014-00027
Event Type: Malfunction
Date Received: April 16, 2014
Date of Event: March 20, 2014
Report Date: March 20, 2014
Manufacturer: VOLCANO CORPORATION
Product Code: DTK
PMA / PMN Number: K122585
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS DEVICE WAS NOT RETURNED TO THE MFR. ALSO, THE SERIAL NUMBER AND LOT NUMBER OF THE FILTER SYSTEM WERE NOT AVAILABLE TO BE REPORTED BY THE CLINICAL STAFF. W/O THIS INFO, MFG DOCUMENTATION FOR THIS DEVICE WAS NOT ABLE TO BE REVIEWED TO CONFIRM THE DEVICE MET ALL QUALITY AND MFG RELEASE CRITERIA. IN ADDITION, W/O THIS INFO WE ARE UNABLE TO CONFIRM IF ANY OTHER COMPLAINTS TO DATE HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS DEVICE'S LOT. SINCE IT WAS REPORTED BY THE PHYSICIAN THAT THE DEVICE WAS HARDER TO ADVANCE IN THE PT AND THAT THE DELIVERY CATHETER WAS CAUGHT ON FILTER WEB DURING WITHDRAWAL, THIS REPORT IS BEING SUBMITTED DUE TO AN ABUNDANCE OF CAUTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S SCIENTIFIC AFFAIRS DEPT COMPLETES THE CLINICAL ASSESSMENT FOR THIS CASE.

Description of Event or Problem · 1

THE PHYSICIAN STATED THAT THE DEVICE WAS HARDER TO ADVANCE IN THE PT THAN HE WOULD HAVE EXPECTED AND HE THOUGH THE TIP GOT CAUGHT ON THE WEB AS HE WAS WITHDRAWING IT (PRIOR TO DOCKING THE DEVICE). ONCE PLACED, THE FILTER WAS STABLE; HE EXPERIENCED NO CHANGE IN THE DEVICE'S POSITION IN THE PT. THERE WAS NO CLINICAL SEQUELAE, OR INTERVENTIONS AND THERE IS NO PLANNED F/U DUE TO THIS INCIDENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
234013	CRUX VENA CAVA FILTER SYSTEM-FEMORAL	FILTER, INTRAVASCULAR, CARDIOVASCULAR	DTK	VOLCANO CORPORATION	7024

Patients

Seq	Age	Sex	Outcome	Treatment
1