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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 Material Fragmentation (1261); Material Separation (1562)
Patient Problems Liver Damage/Dysfunction (1954); Pulmonary Dysfunction (2019)
Event Type  Injury  
Manufacturer Narrative

(b)(4). The reported device is not available for evaluation and has been discarded.

 
Event Description

It was reported by the patient that a gunther tulip was implanted in 2009 while they were comatose. In spite of a statement that it was unreported and undocumented, the patient listed the implant date as (b)(6) 2009. The patient stated that it was discovered in their body in 2014. The patient stated that the device caused pain and the device was removed in 2015. The explant date was reported to be (b)(6) 2015. The patient stated that they had post surgery complications that were ignored that lead to the shut down of their liver. The patient states that ¿my vena cava is damaged and oxygenated blood is not circulating in my body¿. The patient stated that they were ¿a very healthy female prior to needing an ivc filter¿. The patient further stated, ¿i spent a year in bed after surgery once i made the attempt to resume my life and work the symptoms started. ¿ further comments made by the patient on the sus voluntary report were, ¿ very hard to diagnose when the acting physician redacts and fails to forward and disclose events of past ct¿s and reports. ¿ she stated she was ¿mocked if you will as over reactive. ¿ she stated the physician said that the ¿symptoms in his interpretation are not related to device less than never addressing the device as the gunther tulip retrievable ivc filter, but constant statements of patient statements are not contributory. ¿ the patient also stated, ¿now near incapacitated. ¿ she stated she ¿switched health care providers and that the new medical team has diagnosed pulmonary hypertension- damaged vena cava post ivc filter removal. ¿ the patient also stated, ¿incurable progressive i am 2 years into a 3 year life prognosis. What would have been prevented if the concealment of relative changes in my body were pro acted upon. I just received this diagnosis 3 weeks ago. ¿.

 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key6712213
MDR Text Key80010759
Report Number1820334-2017-01637
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 OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/13/2017 Patient Sequence Number: 1
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