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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-JUG-TULIP
Device Problems Leak/Splash (1354); Activation, Positioning or SeparationProblem (2906); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/18/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4) investigation is still in progress.

 
Event Description

Description of event according to complainant: upon initial deployment of the tulip filter (jugular), the primary struts did not appear to expand all the way and gain wall apposition. The filter was retrieved and upon the post removal cavagram, there appeared to be some possible extravasation. An angioplasty balloon then was placed in the ivc and inflated to stop the possible extravasation. A second tulip filter (jugular) was then successfully deployed. Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
Manufacturer Narrative

(b)(4). Summary of investigation findings: based on a review of the provided imaging in all likelihood the filter was inadvertently deployed with the feet engaging the ostium of the large vertebral vein inhibiting the filter from deploying appropriately in ivc. Following filter retrieval likely lacerated the vertebral vein ostium. Investigation found no evidence to suggest the product was not manufactured according to specifications and there is no reason to believe the problem was inherent in the filter. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to complainant: upon initial deployment of the tulip filter (jugular), the primary struts did not appear to expand all the way and gain wall apposition. The filter was retrieved and upon the post removal cavagram, there appeared to be some possible extravasation. An angioplasty balloon then was placed in the ivc and inflated to stop the possible extravasation. A second tulip filter (jugular) was then successfully deployed. Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
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Brand NameGUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
4632 bjaeverskov
DA
Manufacturer Contact
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key5305615
MDR Text Key34584620
Report Number3002808486-2015-00191
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/01/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-1-JUG-TULIP
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 Received12/04/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/22/2013
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: 12/17/2015 Patient Sequence Number: 1
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