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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 Positioning Failure (1158); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/30/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog #: igtcfs-65-1-jug-tulip. Investigation is still in progress.

 
Event Description

Description of event according to the initial reporter: the catheter with the filter in it would not advance further down into the sheath. The doctor pulled the delivery catheter out. He hand injected contrast and the contrast came out the side of the sheath. The doctor put a wire down and removed the sheath. He completed the procedure successfully over that wire with a new filter kit. Patient outcome: there was no harm to the patient.

 
Manufacturer Narrative

Manufacturer ref# (b)(4). Catalog#: igtcfs-65-1-jug-tulip. (b)(4). Summary of investigational findings: the blue sheath and the introducer with filter inside the protection sheath were returned. The red locking mechanism is not pressed, ie the system is still locked. The blue sheath is severely penetrated approx. 18. 5-19. 5cm from the fitting and two kinks are noted close to the penetration. The protection sheath is kinked in the area, where the filter is loaded to the introducer. The tip of the protection sheath is slightly squeezed. Due to of the kinks, the root cause for the reported event is determined to be a difficult approach in the patient (eg. Tortuous anatomy) and user technique. Under normal conditions the introducer sheath is strong enough to accomplish the procedure, but it may kink if excessive force is used to advance it through tortuous anatomy and the filter legs may be prone to exceed the sheath wall, if advanced through a kinked sheath. The ifu states that excessive force should not be used to place the filter. It is noted that the event did not harm the patient and that the procedure was successfully completed by use of a new filter kit. No evidence to suggest that this device was not manufactured according to specifications. Cook medical will continue to monitor for similar events. This report is required by the fda under 21 cfr part 803.

 
Event Description

Description of event according to the initial reporter: the catheter with the filter in it would not advance further down into the sheath. The doctor pulled the delivery catheter out. He hand injected contrast and the contrast came out the side of the sheath. The doctor put a wire down and removed the sheath. He completed the procedure successfully over that wire with a new filter kit. Patient outcome: there was no harm 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 Key6035876
MDR Text Key57689213
Report Number3002808486-2016-01250
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 10/03/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/18/2016
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? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/11/2016
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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