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

Model Number G52916

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "when they went to deploy the device (g52916-igtcfs-65-1-jug-tulip) ((b)(4)), the filter would not open up.The facility elected to use a sister hospitals device (a g52918-igtcfs-65-1-uni-tulip) ((b)(4)).When they went to deploy this device, it deployed prematurely and it was tilted.A third device (g34309-igtcfs-65-1-jug-celect-pt) was opened and used to complete the procedure successfully".Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of (b)(6) (importer).Manufacturers ref# (b)(4).G1) name and address for importer site: (b)(6).Registration no.: (b)(4).Summary of investigational findings: investigation is based on event description only.The filter would not expand and was replaced without any harm to the patient.No product was returned and no imaging was provided.Therefore, it would be inappropriate speculate at what may or may not have caused the filter not to open.However, it is previously seen that the filter legs may be somehow obstructed from fully expanding due to e.G.Ivc anatomical conditions, clots or if the filter is not placed in ivc.No evidence to suggest that this device was not manufactured according 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.

Event Description

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

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR 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: 8211730
• MDR Text Key: 132570655
• Report Number: 3002808486-2018-01540
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)210405(10)E3709389
• Combination Product (y/n): N
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2021
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E3709389
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/07/2018
• Device Age: 8 MO
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1