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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JUG
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Fatigue (1849); Pain (1994); Blood Loss (2597); No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Investigative information: 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 "tulip, migration, unable to be retrieved, abdominal and back pain, bleeding, muscle fatigue". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. It is unknown if the reported bleeding, abdominal pain, back pain and muscle fatigue due to device is directly related to the filter and unable to identify a corresponding failure mode at this point in time. Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement. 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. There is 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
Plaintiff alleges treatment blood clots in 2007 without further explanation.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation.
 
Event Description
It is alleged the patient received a gunther tulip filter on (b)(6) 2006 at (b)(6). Dr. (b)(6) allegedly placed the filter. It is alleged that patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). Investigation / evaluation. The device was not returned to assist in the investigation. No information has been provided regarding the event. We have investigated, based on the information received to date and are closing the report until further information is received. It is impossible to comment on alleged injuries. There is no information to suggest the device was not manufactured to specifications. If additional information is received, the report will be re-opened for further investigation. We have notified the appropriate personnel and will continue to monitor for similar events.
 
Event Description
It is alleged the patient received a gunther tulip filter on (b)(6) 2006 at (b)(6). Dr. (b)(6) allegedly placed the filter. It is alleged that patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e. G. , the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu. It has not been possible to fully investigate or evaluate this 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
It is alleged the [pt] received a gunther tulip filter on (b)(6) 2006 at (b)(6) medical center in (b)(6). It is alleged that [pt] was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested.
 
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 08/02/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2006 via the right internal jugular vein due to deep vein thrombosis and expected prolonged bed rest. Plaintiff is alleging device migration and is device unable to be retrieve. Plaintiff alleges bleeding, abdominal pain, back pain and muscle fatigue due to device.
 
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Brand NameGUNTHER TULIP JUGULAR VENA CAVA FILTER SET
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
8123392235
MDR Report Key5811576
MDR Text Key250022333
Report Number1820334-2016-00656
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIGTCFS-65-JUG
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 Received08/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/01/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/21/2016 Patient Sequence Number: 1
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