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 COOK CELECT® PLATINUM 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 COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-CELECT-PT
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Investigation is still in progress.(b)(4).
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a cook celect platinum filter on (b)(6) 2016." 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 number: unknown but referred to as a cook celect platinum filter.(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 cook celect platinum filter on (b)(6) 2016." 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).Outcome attributed to device: tilt (minor filter tilt of 6-10 degrees is anticipated in ifu).
 
Event Description
Additional information received on 2/14/17 pps - date of implant: (b)(6) 2016, reason: dvt.Implanted cook celect plat (but no lot number provided).Placement physician: (b)(6).Medical facility: (b)(6).Outcome attributed to device: tilt.
 
Manufacturer Narrative
(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.
 
Manufacturer Narrative
Exemption number e2016032.(b)(4).Corrected data based on new information received: serious injury to malfunction.Ec method code updated.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 "tilt" cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter tilt is a known potential complication of vena cava filters.Among other causes, filter tilt may be associated with placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve devices passing through a filter, or a failed retrieval attempt.Excessive filter tilt may result in loss of filter efficiency.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.Other text : exemption number e2016032.(b)(4).Corrected data based on new information received: serious injury to malfunction.Ec method code updated.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 "tilt" cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter tilt is a known potential complication of vena cava filters.Among other causes, filter tilt may be associated with placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve devices passing through a filter, or a failed retrieval attempt.Excessive filter tilt may result in loss of filter efficiency.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.
 
Event Description
Patient allegedly received an implant on (b)(6) 2016 via the left common femoral vein due to deep vein thrombosis.Patient alleges tilt.Patient further alleges severe pain in left groin and from knee to hip.
 
Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: (b)(6).Registration no.: (b)(4).Blank fields on this form indicate the information is unknown or unavailable, or unchanged.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Event Description
No additional information has been provided at this time.
 
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: (b)(4).Additional information: investigation is reopened due to additional information provided.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 "celect pt: tilt , pain- updated sfc." cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter tilt is a known potential complication of vena cava filters.Among other causes, filter tilt may be associated with placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve devices passing through a filter, or a failed retrieval attempt.Excessive filter tilt may result in loss of filter efficiency.Unknown if the reported pain is directly related to the filter.Lot number is unknown, but the device is manufactured and inspected according to specifications, and the celect-pt is manufactured and inspected according to specifications.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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COOK CELECT® PLATINUM 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
MDR Report Key6144383
MDR Text Key61421014
Report Number3002808486-2016-01466
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Distributor Facility Aware Date11/22/2016
Date Manufacturer Received05/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Weight67
-
-