MAUDE Adverse Event Report: WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-JP-JUG-TULIP

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2012

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.Summary of investigational findings: returned device is investigated.A severe kink appeared next to the cup that push the grasping hook forward.The red safety button was not adequately released, consequently it was not possible to push the grasping hook forward.Despite the safety button got released it was still not possible to push the grasping hook forward.This is often experienced if coagulated blood is inside the filter introducer.The filter introducer was then separated.The yellow catheter was removed and the cannula with the grasping hook was exposed.The introducer was then cut approx.10 cm from distal end.It was then revealed that the grasping hook stuck in the cannula.It was now possible to push the metal knob back and forth.During manufacturing of igtcfs-65-jp-jug-tulip the metal knob is pushed and the grasping hook released to load the filter to the introducer system.Therefore, it is most unlikely, that the release mechanism or grasping hook was not functioning, when dispatched from wc.It is possible, the difficulty encountered is due to the red safety button not being adequately released or the grasping hook is sticking due to coagulated blood/fibrin.When the filter finally released by advancing the sheath over the filter, it is most likely, that this is caused by the manipulation and that the filter was released from the grasping hook inside the filter introducer.However, it is not possible to conclude an exact root cause of this event.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: the procedure was conducted as labeled.The device was inserted from left jugular vein to place in ivc.The physician attempted to push the metal knob to release the filter, but the knob was very stiff and could not be pushed.Therefore he tried to advance the sheath over the filter.However, when the upper part of the filter got in the sheath a little, the resistance disappeared and the filter was detached from the filter introducer.The detached filter was retrieved by using gtrs-200-rb and then another igtcfs-65-jp-jug-tulip was used instead to complete the procedure.Patient outcome: there have been no adverse effects to the patient.The filter is to be retrieved 2 weeks later.

• Brand Name: GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH
• 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: 6265980
• MDR Text Key: 65354338
• Report Number: 3002808486-2017-00035
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)150308(10)E2886454
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-JP-JUG-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2012
• 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