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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem Complete Blockage (1094)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Weight Changes (2607)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog# is unknown but referred to as cook celect filter. (b)(4). Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: "i had a cook celect ivc filter placed in my vein prior to back surgery in 2012. All went well. The filter was not removed as i knew knee surgery would come soon. No doctors suggested it needed to be removed. In (b)(6) 2014 i had the knee surgery and thus began a nightmare of problems which i later learned resulted from the filter becoming clogged. None of the doctors at the time diagnosed this and i was in the hospital 70 days and required a second surgery due to infection because the incision was not healing due to the enormous amount of fluid in my system. I gained 60 pounds within a short period of time and was not eating much at all because i felt so sick. A year later i went to the (b)(6) clinic who properly diagnosed the problem- the filter was clogged plus the vein below in 3 places. They removed it, but 2 days later i had internal bleeding. Surgery and a 10 days hospital stay followed. After that came an infection requiring daily wound care for 9 months. I remained weak for 3 years. My legs remain water logged and walking difficult as a result. " patient outcome: removal of device, probably two years or more later. Internal bleeding, infection, water retention and difficult mobility.

 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key7262717
MDR Text Key100006749
Report Number3002808486-2018-00228
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 PATIENT
Type of Report Initial,Followup
Report Date 04/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/12/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date02/01/2018
Event Location No Information
Date Manufacturer Received03/20/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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