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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 Complete Blockage (1094); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pain (1994); Thrombus (2101); Perforation of Vessels (2135); Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Evaluation: it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Document review was completed and included the following: review of complaint history, device history record, mi, qc, specifications. 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. 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.
 
Manufacturer Narrative
Attorney information updated. (b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information was received on 08/03/2016 as follows: the plaintiff allegedly received the device implant on (b)(6) 2007 via the jugular vein due to extensive dvt. The plaintiff alleges device is unable to be retrieved, device is clogged, bleeding, blood clots, severe pain, collapsed veins in right lower leg and severe pain, infections due to clogged veins.
 
Manufacturer Narrative
William cook (b)(4) initially reported event under mfr report # 3002808486-2016-00373. New information was received identifying that the product was a cook inc. Manufactured device. An updated emdr report was submitted under cook inc. Mfr report # 1820334-2016-00846, follow up # 1. This was in reference to william cook (b)(4) mfr report # 3002808486-2016-00373. Cook is now submitting an initial report to correct this issue. Blank fields on this form indicate the information is unknown or unavailable. (b)(4). Evaluation- the device was not returned to assist with the investigation. No information regarding the event was provided. We have investigated based on the information received to date, and are closing the report until further information is received for investigation. Impossible to comment on the alleged injuries. There is no evidence to suggest the device was not manufactured to specifications. If additional information is received, the report will be re-opened for further investigation.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received several cook celect filters and gunther tulip filters in (b)(6) 2007 at (b)(6) medical center in (b)(6). " 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
Initial mdr was submitted by william cook europe under reference # 3002808486-2016-00373. Additional information provided on (b)(6) 2016 determined this device was manufactured by cinc. Patient code: no known consequences reported. Device code: no known device problem reported. Evaluation- the device was not returned to assist with the investigation. No information regarding the event was provided. We have investigated based on the information received to date, and are closing the report until further information is received for investigation. Impossible to comment on the alleged injuries. There is no evidence to suggest the device was not manufactured to specifications. If additional information is received, the report will be re-opened for further investigation.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received several cook celect filters and gunther tulip filters in (b)(6) 2007 at kaiser permanente medical center in (b)(6). " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
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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 (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key5920892
MDR Text Key109811847
Report Number1820334-2016-00846
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 05/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received08/03/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/01/2009
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: 09/01/2016 Patient Sequence Number: 1
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