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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Material Erosion (1214); Fracture (1260); Appropriate Term/Code Not Available (3191)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Internal Organ Perforation (1987); Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative

(b)(4). This report includes information known at this time. A follow-up medwatch report will be submitted if additional relevant information become available.

 
Event Description

Patient allegedly received a bird's nest ivc filter implant on (b)(6) 2001 via left common femoral vein due to right femoral artery dvt (deep vein thrombosis). Patient is alleging fracture, embedment, perforation, hematuria, blood with bm, pain, ivcf erosion into the duodenum. Per a ct (computed tomography) scan of the abdomen and pelvis dated (b)(6) 2010, ¿birds nest ivc filter seen with perforation of multiple filter tines into adjacent structures including infrarenal aorta, right psoas, and probably the duodenum. No acute complication such as hemorrhage, inflammation, or free air is seen. No perforation of the ureters, kidneys, or bladder. ¿ per an attempted ivc filter retrieval operative report dated (b)(6) 2010, ¿unsuccessful attempt to retrieve a permanent ivc filter. ¿ per an attempted ivc filter retrieval operative report dated (b)(6) 2010, ¿procedure performed: exploratory laparotomy and removal of the venocaval filter with repair of duodenotomy with veno-veno bypass with caval reconstruction and with extraction of caval filter from aorta. ¿.

 
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Brand NameUNKNOWN
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 Key9249653
MDR Text Key164859284
Report Number1820334-2019-02710
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/29/2019
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 Received01/06/2020
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: 10/29/2019 Patient Sequence Number: 1
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