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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-JUG-TULIP
Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Perforation (2001); Injury (2348); Blood Loss (2597); No Information (3190)
Event Date 08/01/2012
Event Type  Injury  
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer). It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating "plaintiff is alleging the filter is unable to be retrieved¿. Cook will reopen its investigation if further information is received. Filter retrieval is occasionally difficult. This is well-known from published scientific literature where filter retrievals are referred to as simple vs. Complex. Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques. No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e. G. Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.
 
Manufacturer Narrative
Manufacturer ref# (b)(4). Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. Investigation is still in progress.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter and a cook celect filter on (b)(6) 2011 and on (b)(6) 2012. The [pt] states that both filters were placed at (b)(6). " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). Investigation is still in progress.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter and a cook celect filter on (b)(6) 2011 and on (b)(6) 2012. The [pt] states that both filters were placed at (b)(6) center. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e. G. , the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu. It has not been possible to fully investigate or evaluate this event based on the limited information provided to date. Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter and a cook celect filter on (b)(6) 2011 and on (b)(6) 2012. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information was received on 09jun2016 as follows: plaintiff allegedly received an implant on (b)(6) 2012 via the jugular vein due to knee replacement surgery. Plaintiff also allegedly received a first filter implanted on (b)(6) 2011 ((b)(4)). Plaintiff is alleging the second filter is unable to be retrieved. Patient alleges successful retrieval of the first filter on (b)(6) 2011. Patient alleges attempted retrieval of the second filter on (b)(6) 2012.
 
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Brand NameGUNTHER TULIP NAVALIGN 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
bjaeverskov 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632, IN 47404
8004574500
MDR Report Key5690403
MDR Text Key217094264
Report Number3002808486-2016-00340
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/05/2015
Device Catalogue NumberIGTCFS-65-1-JUG-TULIP
Device Lot NumberE2884459
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/09/2016
Device Age4 MO
Event Location No Information
Date Manufacturer Received03/29/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/05/2012
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: 06/01/2016 Patient Sequence Number: 1
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