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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 Problems Break (1069); Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)
Patient Problems Abdominal Pain (1685); Hematoma (1884); Bowel Perforation (2668)
Event Date 07/31/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Catalog# is unknown but referred to as cook celect filter. Name and address for importer site: (b)(4). No code available for bowel perforation. (b)(4) - type of investigation not yet determined. Corrected data compared with medwatch report mw5078870: product problem, hospitalization, celect, cook, inc (b)(4). Model# celect ivc filter, lot# unknown. Investigation is still in progress. Mw5078870. (b)(4).
 
Event Description
Description of event according to initial reporter: "a (b)(6) male, with a celect filter placed at an unknown date 9 years ago. Broken, one full leg migrated and apparently projecting through the ra into the lung effectively skewering it with some pericardial effusion. In abdomen one leg was skering duodenum with hematoma. Patient had abdominal pain. The filter was removed (b)(6) 2018 and we are assessing what to do about the migrated leg as it does appear to be "symptomatic" with the pericardial effusion. He may well need open heart surgery. Patient was discharged and awaiting follow-up cta. Information received from medwatch report mw5078870: "had cook celect filter placed in ivc 8 years ago after polytrauma. Presented in 2018 with abdominal pain. Ct scan showed strut of filter penetrated duodenum with intramural hematoma. A single fractured strut was found within pericardiac tissues surrounding the right atrium. Extending into the adjacent right lung. Filter was removed from ivc on (b)(6) 2018 using endovascular techniques. Patient will undergo additional testing and evaluation to determine treatment plan for remaining strut in pericardial tissues/lung. Patient outcome: patient is awaiting cta and follow-up. Patient was discharged.
 
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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 Key7804182
MDR Text Key117829956
Report Number3002808486-2018-00955
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,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date08/06/2018
Event Location No Information
Date Manufacturer Received12/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/22/2018 Patient Sequence Number: 1
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