Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Anxiety (2328); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Lot#: unknown as information was not provided.Catalog#: unknown but referred to as a gunther 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.(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) 2012 ((b)(4)) and a gunther tulip filter on (b)(6) 2012 ((b)(4))." 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 gunther tulip filter.Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057.(b)(4).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) 2012 ((b)(4)) and a gunther tulip filter on (b)(6) 2012 ((b)(4))." 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 03/20/2017 as follows: the patient allegedly received the device implant via right femoral vein on (b)(6) 2012 as treatment for pulmonary embolism, with anticoagulation contraindicated.Prior to the implant the patient had been in the hospital for approximately one month due to multiple injuries sustained in a motorcycle accident.The patient is alleging migration, device difficult to retrieve, and anxiety.
 
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 migration, device difficult to retrieve, and anxiety".Cook will reopen its investigation if further information is received.Manipulation in the area of the filter implant may cause migration or contribute to change in the filter configuration and vena cava.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.(b)(4).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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA  4632
Manufacturer Contact
thomas hessner kirk
400 daniels way
bloomington, IN 47404
8004574500
MDR Report Key6208740
MDR Text Key63407135
Report Number3002808486-2016-01542
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
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 07/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIGTCFS-65-1-FEM-TULIP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date12/13/2016
Date Manufacturer Received07/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Weight98
-
-