MAUDE Adverse Event Report: GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G52916

Device Problem Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Similar to device marketed under pma/510(k): k172557.Investigation is still in progress.

Event Description

According to the initial reporter the device was used for urgent ivc filter placement.Approach was gained from the right jugular vein.The physician felt slight resistance at the puncture point.There was severe tortuosity in the ivc.[the first device (e4081212)] (b)(4).The delivery system was advanced to the target site.Since the filter did not expand as much as expected after the filter was advanced outside the sheath, the physician suspected that the filter still attached to the filter catheter went into the ovarian vein inadvertently.Therefore, he once closed the filter legs by advancing the sheath (during sheath advancement over the filter, he felt slight resistance.) and when he moved the sheath to the ivc side to adjust the position, the filter became detached from the filter catheter inside the sheath without pushing the red safety button or release button.He cut off the sheath at the proximal side, then advanced a 9fr sheath over the remained section of the gunther 7fr sheath and the filter was retrieved with (b)(6)medtronic¿s snare device named gn500.[the second device (e4081279)] (b)(4).The first device was replaced with the second one.The delivery system was advanced to the target site from the same approach point, then the physician pushed the release button.However, the filter could not be detached from the filter catheter.He pushed it several times, but the filter could not be detached.After that, when he moved the device slightly, a pop noise was heard and the filter became detached and placed in the target site.Patient outcome: there have been no adverse effects to the patient reported.

Event Description

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

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: slight resistance was felt when re-sheathing the filter to adjust the position and during adjustment the filter detached inside the sheath.The proximal end of the sheath was cut off and after advancing a larger sheath over the distal end, the filter was retrieved with a snare.Another filter was placed, but the replacement device did not detach ((b)(4)).The jugular introducer, the filter, and the coaxial introducer system were returned.The jugular introducer was kinked/curved 370mm from the distal end, the red locking mechanism was not pressed down, ie the system was still locked.The grasping hook had straightened and stuck in hardened blood.A lot of hardened blood was noted on the filter, too, and caused a minor discrepancy in the width of the secondary filter legs.The sheath was squeezed 83mm from the distal end and some indentations were noted in the most distal tip.The sheath was cut 14mm from the hub as reported, but the cutting surfaces did not match one another, thus suggesting that a small part of the sheath was missing.The exact reason for the filter to detach inside the sheath cannot be determined, but the straightened grasping hook may suggest a strong manipulation when re-sheathing the filter and following the straightening caused the filter to unintendedly detach inside the sheath.There are adequate controls in place to ensure the device was manufactured to specifications.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 NAVALIGN JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• MDR Report Key: 12280172
• MDR Text Key: 265218157
• Report Number: 3002808486-2021-01677
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)240304(10)E4081212
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2024
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E4081212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2021
• 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