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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-UNI
Device Problems Difficult To Position (1467); Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/18/2014
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Similar to device under 510(k) (b)(4). (b)(4). Summary of investigational findings: long dilator, blue sheath, jugular introducer, and femoral introducer with loaded filter returned. Secondary filter legs/wires are deformed and pulled upwards against filter hook. Also, marks were noted on the tip of the introducer sheath. Both observations confirming, that attempts had been made to reposition the pre-exposed filter as reported. The exact reason for the straightened filter hook cannot be determined, but after retrieval, attempts may have been made to pull the filter from the piston/cup without advancing the introducer. Ifu, warning: the slightly expanded filter can be repositioned proximally or distally, but not pulled back into the sheath; doing so will most likely damage the filter. No evidence to suggest that device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.

 
Event Description

While trying to deploy the ivc filter through femoral approach, we were not able to reposition the filter and the hook of the filter was found caught in the venous wall and it stained the vessel. Later it was found that the hook was not in j shape.

 
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Brand NameGUNTHER TULIP JUGULAR & FEMORAL 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 Key6272091
MDR Text Key65571430
Report Number3002808486-2017-00053
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation
Type of Report Initial
Report Date 08/21/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/24/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-UNI
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/02/2014
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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