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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problems Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Bruise/Contusion (1754); Blood Loss (2597); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 21/dec/2017 as follows: patient received an implant on (b)(6) 2007 via the right internal jugular vein due to pulmonary embolism and deep vein thrombosis. Patient is alleging filter legs embedded, bleeding, bruising easily, blood thinners and monthly inr check due to the device. Patient alleges that the device is unable to be retrieved. Retrieval was attempted on (b)(6) 2008 and (b)(6) 2008.
 
Manufacturer Narrative
A filter that is embedded in the wall of the ivc may be difficult to retrieve. 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.
 
Event Description
This additional information received on 21/dec/2017 as follows: patient received an implant on (b)(6) 2007 via the right internal jugular vein due to pulmonary embolism and deep vein thrombosis. Patient is alleging filter legs embedded, bleeding, bruising easily, blood thinners and monthly inr check due to the device. Patient alleges that the device is unable to be retrieved. Retrieval was attempted on (b)(6) 2008 and (b)(6) 2008.
 
Manufacturer Narrative
(b)(4). Corrected data based on new information received: adverse event to product problem. Serious injury to malfunction. Blank fields on this form indicate the information is unknown or unavailable, or unchanged. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Manufacturer Narrative
The event is currently under investigation. A supplemental report will be submitted upon completion.
 
Event Description
It is alleged that the plaintiff received a gunther filter on (b)(6) 2007. It is alleged that the plaintiff was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7123140
MDR Text Key258205662
Report Number1820334-2017-04441
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 01/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/15/2017 Patient Sequence Number: 1
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