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

Catalog Number IGTCFS-65-JP-JUG-TULIP

Device Problems Difficult to Advance (2920); Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k): k172557.Investigation is still in progress.

Event Description

Description of event according to initial reporter: ivc filter placement was performed in emergency by the right internal jugular vein approach.When the user was advancing the filter introducer through the previously placed sheath, he felt resistance.He checked what was wrong, then found that the filter penetrated the sheath and protruded.He managed to have the protruded part back into the sheath as much as possible by using an angio catheter and wire guide, then removed the entire device.The first device was replaced with another igtcfs-65-jp-jug-tulip of the same lot#, but because the same thing occurred at the same site, he removed the entire device by the same way as he did on the first device.The second device was replaced with gunther femoral approach device.The approach site was changed to the femoral as well and the procedure was completed with the third device.Patient outcome: there have been no adverse effects to the patient reported.It was confirmed that there was no damage to the vessel due to the event.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: it was reported that resistance was felt when advancing the filter through the sheath and filter penetrated the sheath wall.This happened twice, why changed to femoral approach.Two jugular introducer systems and two sheaths with the tulip filter sticking inside were returned.An evaluation of the returned jugular introducers revealed no sign of damage or nonconformance.The evaluation of the sheaths is referenced sheath a and sheath b: sheath a was twisted and a kink was noted 412mm from distal tip.Two penetrations were noted, one 461mm from distal tip and another penetration 455mm from the distal tip with a primary filter leg still penetrating from inside.Sheath b was kinked 248mm and 427mm from distal end, respectively, and 448mm from distal tip a primary filter leg was penetrating from inside.It is noted that the approach site was changed to the femoral and that the procedure was completed with the third device.Under normal conditions the sheath is strong enough to accomplish the procedure, but it may kink if advanced through tortuous anatomy and following, the filter legs may be prone to exceed the sheath wall, if advanced through a kinked sheath.The instructions for use warn that excessive force should not be used to place the filter.There are adequate controls in place to ensure that this type of device is manufactured to specifications and it was assessed that because any discovered non-conformances were properly dispositioned before qc release, there is evidence that the dhr was fully executed.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: GUNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 10095572
• MDR Text Key: 196585479
• Report Number: 3002808486-2020-00567
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002037738
• UDI-Public: (01)10827002037738(17)230317(10)E3964279
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2023
• Device Catalogue Number: IGTCFS-65-JP-JUG-TULIP
• Device Lot Number: E3964279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1