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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135); No Information (3190)
Event Date 07/29/2016
Event Type  malfunction  
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).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 gunther tulip filter.Initial reporter) corrected.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) 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 received on 01/27/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2013 via the right internal jugular vein due to deep vein thrombosis and pulmonary embolism.Plaintiff is alleging vena cava perforation and embedment.It is alleged that the device was removed on (b)(6) 2016.
 
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 "vena cava perforation, embedded".Cook will reopen its investigation if further information is received.Filter perforation of the vena cava wall is a known risk reported in the published scientific literature.Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.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 Name
UNKNOWN
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 Key6208733
MDR Text Key63412662
Report Number3002808486-2016-01564
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
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 08/01/2017
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 NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date12/19/2016
Date Manufacturer Received07/12/2017
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 Age74 YR
Patient Weight72
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