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

Catalog Number IGTCFS-65-2-UNI-TULIP

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: jugular introducer with filter withdrawn into protection sheath is returned together with blue sheath and long dilator.A 3 cm penetration is found approx.18-21 cm from distal tip of sheath and a minor kink is found approx.18 cm from proximal end.Red locking mechanism is not pushed, but when activated the filter could be moved as intended.The exact reason for the filter to penetrate the sheath cannot be determined.It is reported that sheath passed easily, but it may have been somehow kinked during advancement via left internal jugular vein.Under normal conditions the sheath is strong enough to accomplish the procedure, but the sheath may kink if somehow exposed to excessive force during advancement.If filter is advanced through a kinked sheath, the filter may be prone to exceed the sheath wall.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: introducer sheath inserted via left internal jugular vein (right ij and subclavian occlusion).Sheath passed easily into ivc.As filter was advanced through sheath, exited side-wall of sheath just beyond the confluence of the brachiocephalic veins.The filter was pulled back into sheath and the sheath removed.Patient outcome: the patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL 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 Key: 6272432
• MDR Text Key: 65580201
• Report Number: 3002808486-2017-00092
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529264
• UDI-Public: (01)10827002529264(17)170108(10)E3170630
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58