COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET

MDR report key: 2444207 · Received February 3, 2012

Report

Report Number: 3002808486-2012-00001
Event Type: Death
Date Received: February 3, 2012
Date of Event: January 3, 2012
Report Date: January 4, 2012
Manufacturer: WILLIAM COOK EUROPE
Product Code: DTK
PMA / PMN Number: K061815
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). INVESTIGATION IS IN PROGRESS.

Description of Event or Problem · 1

THE PHYSICIAN WAS TAKING A RIGHT FEMORAL APPROACH DURING THE PROCEDURE. WHEN A CAVAGRAM WAS DONE THE TECHNICIAN AND THE PHYSICIAN NOTED SOMETHING DID NOT LOOK RIGHT. CONTRAST WAS INJECTED AND FILLED THE RIGHT ILIAC FINE AND O INTO THE LEFT ILIAC. IT SLOWED FROM THE LEFT ILIAC AND UP THE VENA CAVA. THE TECHNICIAN FELT LIKE THERE IS POSSIBLY A CLOT CAUSING THE CONTRAST TO SLOW. THE PHYSICIAN DECIDED TO PROCEED WITHOUT DOING ANOTHER CAVAGRAM. THE FILTER WAS PLACED SUCCESSFULLY. A FEW HOURS POST PROCEDURE THE PT CODED FROM A MASSIVE PULMONARY EMBOLISM. PT EXPIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET	DTK FILTER, INTRAVASCULAR CARDIOVASCULAR	DTK	WILLIAM COOK EUROPE	NA	E2825137

Patients

Seq	Age	Sex	Outcome	Treatment
1	87 YR		Death\| L\| S