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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 Difficult To Position (1467); Material Twisted/Bent (2981)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/06/2017
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Description of event according to initial reporter: "the physician went to deploy the gunther tulip navalign jugular vena cava filter per jugular approach. Went to deploy, unsheathed, and the filter came off correctly. The physician was not happy with filter position so the filter was re-sheathed for repositioning. At that time the filter came off the deployment system and the legs were tangled and failed to re-open, lodging in the patients ivc. Using a snare, the physician was able to retrieve the filter with no harm to the patient. Another filter was used to complete the procedure. " patient outcome: no adverse effects to the patient.

 
Manufacturer Narrative

(b)(4). Summary of investigational findings: since no product was returned and no imaging was provided it would be inappropriate to speculate at what may or may not have occurred based on the limited information made available to us concerning filter legs, which tangled and failed to open after repositioning. However, it is seen before that the filter legs can be somehow obstructed from fully expanding due to e. G. Ivc anatomical conditions, clots or if the filter is not placed in ivc. It is noted, that the filter was retrieved with a snare and that another filter was used to complete the procedure. No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to initial reporter: "the physician went to deploy the gunther tulip navalign jugular vena cava filter per jugular approach. Went to deploy, unsheathed, and the filter came off correctly. The physician was not happy with filter position so the filter was re-sheathed for repositioning. At that time the filter came off the deployment system and the legs were tangled and failed to re-open, lodging in the patients ivc. Using a snare, the physician was able to retrieve the filter with no harm to the patient. Another filter was used to complete the procedure. " patient outcome: no adverse effects to the patient.

 
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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 Key6291916
MDR Text Key66217499
Report Number3002808486-2017-00242
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 HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/10/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/01/2017
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?
Distributor Facility Aware Date01/11/2017
Device Age4 mo
Event Location No Information
Date Manufacturer Received01/12/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/09/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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