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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem Material Separation (1562)
Patient Problem Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative

Initial reporter: contact information not provided. Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown. This report includes information known at this time. A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.

 
Event Description

It was reported, a female patient had a gianturco-roehm bird's nest femoral vena cava filter implanted in the inferior vena cava on (b)(6) 2005. A computed tomography (ct) was done (at another hospital) where it was discovered the implant had perforated or broken. Additional information was provided by the patient: the gianturco-roehm bird's nest femoral vena cava filter was found to have perforated the iliac artery and four prongs were broken. The portions have not been retrieved because, reportedly, it is too life-threatening at this point. The patient has reported a burning sensation in the abdomen and occasional pain in the upper legs. The patient has had (or possibly still has) kidney cancer and cirrhosis and has checkups every six months. Per the patient, (b)(4) is listed on the product card. Product and lot numbers are unknown. The complaint device remains implanted; therefore, is not available for return to the manufacturer.

 
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Brand NameGIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8546708
MDR Text Key143040700
Report Number1820334-2019-00931
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2019
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 TREATMENT DATA
Date Received: 04/24/2019 Patient Sequence Number: 1
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