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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 Patient Device Interaction Problem (4001)
Patient Problems Internal Organ Perforation (1987); Pain (1994); Bowel Perforation (2668)
Event Date 06/01/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Auyang, p. , et al. , "examining outcomes and causes of symptomatic long-term indwelling inferior vena cava filters", journal of vascular surgery, 2018, vol. 67, no. 6, e158-e159. Blank fields on this form indicate the information is unknown or unavailable. Catalog# is unknown but referred to as cook celect filter. (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to article: in the abstract authored by auyang et al. A review was completed of 15 patients (mean age 52. 8) of whom 3 patients received treatment with a celect filter. 3 male patients listed in the abstract each received a celect filter and each patient experienced pain. A male patient (age (b)(6)) experienced structure involvement in the duodenum, aorta and gi bleed and abdominal pain with symptoms occurring for 24 months total. Filter was removed by open surgery. Auyang et al. State that the aim of the study was to "correlate the symptoms to the location of the ivc filter struts and to examine outcomes" (2018, p. E158). The authors stated that the etiology of pain was determined to be directly correlated the area where the ivc struts protruded in the patient. Patient outcome: the patient experienced a resolution to the pain. The filter was removed by open surgery.
 
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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 (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key7994563
MDR Text Key124669797
Report Number3002808486-2018-01235
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 health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date10/10/2018
Event Location No Information
Date Manufacturer Received12/04/2018
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: 10/23/2018 Patient Sequence Number: 1
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