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 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-jp-jug-tulip.(b)(4).Similar to device under 510(k) k090140.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: the device was approached from the right jugular vein.The physician decided the target site, then pushed the metal knob of the filter introducer to place the filter.When he attempted to remove the introducer from the patient after that, the filter moved as if it was still connected to the introducer or being dragged by a thread although the filter appeared to be detached from the filter introducer.After several attempts of withdrawing and rotating the introducer, the filter could be detached from the introducer and placed.Patient outcome: there have been no adverse effects to the patient reported.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi) (b)(4).Summary of investigational findings: the tulip filter was placed in the infrarenal location, without evidence of significant tilt.Per the complaint report, but not readily visualized on the provided series of images, the deploying physician had a difficult time removing the introducer device after the filter was apparently disconnected from the grasping hook.While attempting to withdraw the device, "the filter moved as if it was still connected" to the device, although this attachment was not readily visualized under fluoroscopy.After multiple attempts of withdrawing and rotating the introducer, the device was successfully removed without immediate harm or displacement of the ivc filter.A follow-up venogram was not performed to confirm no ivc injury.Although the described incident was not clearly captured on the fluoroscopic images submitted, what likely occurred was the grasping hook inadvertently became engaged with the wall of the ivc.When attempting to withdraw the introducer device through the sheath this resulted in displacement of the ivc wall causing the filter to move with each attempt.The grasping hook was eventually disengaged from the wall of the ivc by re-advancing the grasping hook and rotating the device to free it.The ifu describes applying slight back tension while pushing the release button.Potentially, too much tension could result in the filter not truly being released from the grasping hook.Or the alternative, not enough tension may not help center the hook within the ivc thus allowing the grasping hook to come in close proximity and potentially engage with the wall of the ivc.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter and/or the jugular introducer did not perform as intended.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.

Event Description

Description of event according to initial reporter: the device was approached from the right jugular vein.The physician decided the target site, then pushed the metal knob of the filter introducer to place the filter.When he attempted to remove the introducer from the patient after that, the filter moved as if it was still connected to the introducer or being dragged by a thread although the filter appeared to be detached from the filter introducer.After several attempts of withdrawing and rotating the introducer, the filter could be detached from the introducer and placed.Patient outcome: there have been no adverse effects to the patient reported.

• Brand Name: GÜNTHER 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: 7482345
• MDR Text Key: 107216926
• Report Number: 3002808486-2018-00507
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)191018(10)E3508181
• 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: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2019
• Device Catalogue Number: IGTCFS-65-JP-JUG-TULIP
• Device Lot Number: E3508181
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/18/2018
• Device Age: 15 MO
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1