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

Model Number G52918

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Occupation: circulating nurse.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: during a jugular approached ivc filter placement procedure (initial placement) the gunther tulip navalign jugular; femoral vena cava filter set, (b)(4), prematurely deployed inside of the sheath.The physician deployed the filter and then snared it out and placed a bard denali filter in the patient.Patient outcome: the patients outcome was good.The patient did not require any additional procedures due to this occurrence.

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: during a jugular approached ivc filter placement procedure the tulip filter prematurely deployed inside the sheath.The physician deployed the filter and then snared it out and placed a non-cook filter in the patient.The patient outcome was good.A jugular introducer and a tulip filter were returned for product evaluation.Blood/biological matter was present.After soaking the introducer, the release button and the grasping hook got full functionality.The filter was attached to the grasping hook.With the release button released, it required only a light touch on the filter, to detach it.The distal end of the grasping hook looked less u-shaped than expected.Production personnel was measuring and inspected the grasping hook and found that the grasping hook was too small.Other observation was that the grasping hook had a different shape and was pulled.Per the product evaluation, it is unknown what have caused the deformation of the grasping hook, but if the filter is removed without following the procedure this could occur.According to instruction for use excessive force should not be used to place filter.There are adequate controls in place to ensure the device was manufactured to specifications.Based on the provided information and product evaluation a likely cause is that the filter deployed inside the sheath due to excessive force.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 & FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8695129
• MDR Text Key: 148304924
• Report Number: 3002808486-2019-00736
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529189
• UDI-Public: (01)10827002529189(17)211206(10)E3804877
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2021
• Device Model Number: G52918
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Device Lot Number: E3804877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Distributor Facility Aware Date: 05/21/2019
• Device Age: 6 MO
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1