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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC.GUNTHER TULIP VENA CAVAL FILTER

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COOK, INC. GUNTHER TULIP VENA CAVAL FILTER   Back to Search Results
Catalog Number ICTCFS-65-JUG
Event Date 11/22/2006
Event Type  Injury   Patient Outcome  Life Threatening
Event Description

A gunther tulip filter was placed in a pt who had contraindication to anticoagulation that was immobile and at risk for thromboembolization. Ct scan 2 days after placement showed the filter in good position. Five days following placement the pt arrested. A chest x-ray following resuscitation demonstrated migration of the filter to the cavoatrial junction. A subsequent echocardiogram showed the filter within the tricuspid valve. Emergent surgical removal was required. The pt recovered from the surgery, but remains in the intensive care unit and ventilated.

 
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Brand NameGUNTHER TULIP VENA CAVAL FILTER
Type of DeviceCAVAL FILTER
Baseline Brand NameGUNTHER TULIP VENA CAVA FILTER
Baseline Generic NameVENA CAVA FILTER
Baseline Catalogue NumberIGTCFS-65-JUG
Manufacturer (Section F)
COOK, INC.
750 daniels way
po box 489
bloomington IN 47404
Manufacturer (Section D)
COOK, INC.
750 daniels way
po box 489
bloomington IN 47404
Device Event Key775713
MDR Report Key787975
Event Key751934
Report NumberMW1041208
Device Sequence Number1
Product CodeDTK
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 11/28/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/28/2006
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberICTCFS-65-JUG
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Was The Report Sent To Manufacturer? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?

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