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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-TULIP
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Aspiration/Inhalation (1725); Chest Pain (1776); Anxiety (2328); No Information (3190)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog number: unknown but referred to as a cook günther tulip filter. Since catalog number is unknown the 510(k) could be either k090140, k112119 or k121057. (b)(4). Investigation is still in progress.

 
Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2013. " 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). Catalog #: unknown but referred to as a cook günther tulip filter. Expiration date: unknown as lot # is unknown. Since catalog # is unknown the 510(k) could be either k090140, k112119 or k121057. Mfr date unknown as lot# is unknown. It has not been possible to investigate or evaluate this alleged 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 gunther tulip filter on (b)(6) 2013. " 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 1/16/2017 as follows: the patient allegedly received the device implant on (b)(6) 2013. The patient is alleging device is unable to be retrieved, shortness of breath, abdominal pain, swelling in lower extremities, anxiety, and depression.

 
Manufacturer Narrative

Exemption number e2016032. William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer). Manufacturer reference #(b)(4). Corrected data based on new information received: adverse event to product problem. Serious injury to malfunction. 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 "the patient is alleging device is unable to be retrieved, shortness of breath, abdominal pain, swelling in lower extremities, anxiety, and depression¿. 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.

 
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Brand NameGUNTHER TULIP NAVALIGN FEMORAL 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
CH 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov, IN 4632
CH   4632
8004574500
MDR Report Key6192246
MDR Text Key62908485
Report Number3002808486-2016-01515
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
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 Received12/21/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/11/2015
Device Catalogue NumberIGTCFS-65-1-FEM-TULIP
Device LOT NumberE2991604
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date12/08/2016
Event Location No Information
Date Manufacturer Received03/29/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/01/2012
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: 12/21/2016 Patient Sequence Number: 1
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