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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JUG-CELECT-PERM
Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Internal Organ Perforation (1987); Stenosis (2263); Bowel Perforation (2668)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Occupation: non-healthcare professional. Name and address for importer site:(b)(4). Investigation is still in progress.
 
Event Description
Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2009". Additional information received 19oct2018: patient allegedly received an implant on (b)(6) 2009 due to deep vein thrombosis (dvt). Patient alleges tilt, organ perforation. Patient further alleges to have experienced: (b)(6) 2016 emergency room visit due to live bleeding; diagnosed ivc filter in dangerous place and needed to be removed; (b)(6) 2016, remitted with pneumonia; (b)(6) 2016, remitted with deep vein thrombosis (dvt); (b)(6) 2016, lung/liver complications (long term coumadin use required with ivc filter), hospital acquired c-diff infection twice; (b)(6) 2017, surgical hernia repair (damage, prior surgery); (b)(6) 2018, full abdominal reconstruction including multiple hernias and requiring mesh across entire abdomen (major damage prior surgery and extensive scarring). Attempted retrieval on (b)(6) 2016, due to significant leg perforation right gonadal vein and duodenum, one strut/leg left in vertebral body with bony remolding around filler leg, one leg abutting the aorta and moderate tilt, was unsuccessful. Patient outcome: filter successfully retrieved on (b)(6) 2017. "successful inferior vena caval filter retrieval. The filter is intact. ".
 
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Brand NameCOOK CELECT JUGULAR VENA CAVA FILTER SET
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
dk-4632 bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
dk-4632 bjaeverskov 4632
DA   4632
56868686
MDR Report Key8040853
MDR Text Key126219474
Report Number3002808486-2018-01304
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,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2010
Device Catalogue NumberIGTCFS-65-JUG-CELECT-PERM
Device Lot NumberE2284974
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date10/23/2018
Event Location No Information
Date Manufacturer Received05/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/17/2008
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: 11/06/2018 Patient Sequence Number: 1
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