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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 Problem Difficult or Delayed Positioning (1157)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: filter would not release from the hook.After multiple presses of the button, the filter did finally release and the case was completed successfully.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 investigational findings: investigation is solely based on description of event.Based on the limited information provided, it would be inappropriate to speculate on what led to the reported event.It is noted that the procedure was completed successfully.It is known from the literature that excessive back tension could result in deployment difficulties/failure when pressing the release button.The ifu addresses the issue through the statement "while keeping slight back tension on the introducer, push the release button completely to ensure proper release of the filter" and the warning "excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated." no evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
 
Event Description
Description of event according to initial reporter: filter would not release from the hook.After multiple presses of the button, the filter did finally release and the case was completed successfully.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand Name
GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
Type of Device
DTK 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 Key5982385
MDR Text Key55790293
Report Number3002808486-2016-01172
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2016
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
Date Manufacturer Received09/16/2016
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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