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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-UNI-CELECT-PT
Device Problems Premature Activation (1484); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Catalog #: igtcfs-65-1-uni-celect-pt.Name and address for importer site: (b)(4).Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: "we had an issue earlier today with a cook ivc filter that was partially expanded prior to deployment.It was somewhat difficult, but the physician was able to use a snare to safely remove the filter safely without patient compromise." additional information provided (b)(6) 2018: cook representative was informed that a second filter was placed successfully after the first filter failed to deploy.Patient outcome: filter was safely removed without patient compromise.
 
Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: (b)(6).Registration no.: (b)(4).Summary of investigational findings: based on the limited event description and there being no reference to which procedural approach the physician has selected and the limited product provided it would be inappropriate to speculate at what may or may not have caused the filter to partially expand prior to deployment.However, it could be suspected that a jugular approach was selected during the procedure and that the protection sheath was not completely advanced over the filter.The current version of the ifu references this, see section for preparation for jugular approach.5.Straighten the system and then advance the protection sheath over the filter until a confirmed stop is felt (approximately 6 cm).This ensures that the filter is completely inside the tip of the protection sheath.It is noted that the filter was "safely removed without patient compromise" and the patient recieved a second filter that was successfuly placed.There is no evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.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
Description of event according to initial reporter: "we had an issue earlier today with a cook ivc filter that was partially expanded prior to deployment.It was somewhat difficult, but the physician was able to use a snare to safely remove the filter safely without patient compromise." additional information provided (b)(6) 2018: cook representative was informed that a second filter was placed successfully after the first filter failed to deploy.Additional information received from (b)(6) 2018: "the ivc filter was inserted and was noted that the filter had partially expanded and wedged in an ancillary vein off of the ivc prior to deployment.Ivc filter was retrieved with a snare and removed without complication.A new ivc filter was placed in the ivc with no complications." patient outcome: filter was safely removed without patient compromise.
 
Event Description
Additional information received from (b)(6) 2018: "the ivc filter was inserted and was noted that the filter had partially expanded and wedged in an ancillary vein off of the ivc prior to deployment.Ivc filter was retrieved with a snare and removed without complication.A new ivc filter was placed in the ivc with no complications.".
 
Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# pr220199.G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.H11) corrected data compared to medwatch report (mw5076059): b2: required intervention.D3: cook inc.Blomington in united states d10: yes e1: jenny maddi phone# +1(912)486-1506 e2: yes e3: nurse h1: serious injury investigation is still in progress.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.H3 other text : exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# pr220199 g1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113 h11) corrected data compared to medwatch report (mw5076059): b2: required intervention d3: cook inc.Blomington in united states d10: yes e1: jenny maddi phone# +1(912)486-1506 e2: yes e3: nurse h1: serious injury.Investigation is still in progress.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.
 
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Brand Name
COOK CELECT® PLATINUM NAVALIGN UNISET 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 Key7351995
MDR Text Key103274588
Report Number3002808486-2018-00370
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 health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 06/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/07/2021
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT-PT
Device Lot NumberE3687040
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2018
Distributor Facility Aware Date03/01/2018
Device Age1 MO
Date Manufacturer Received06/21/2018
Patient Sequence Number1
Patient Age57 YR
Patient Weight93
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