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

Model Number G52916

Device Problems Premature Activation (1484); Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/10/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device marketed under pma/510(k): k211874.Investigation is still in progress.

Event Description

Description of event according to initial reporter: while the physician was advancing the filter catheter out of the sheath and retracting it into the sheath to adjust the filter position, the filter became detached from the filter catheter, then placed in an undesired site.Therefore, the filter was retrieved with a snare device.The physician considered to replace the filter though, he decided to abandon filter placement itself due to the amount of thrombus and its location.The procedure was finished without placing the filter.Patient outcome: the patient recovered on (b)(6) 2022.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: while the physician was advancing the filter catheter out of the sheath and retracting it into the sheath to adjust the filter position, the filter became detached from the filter catheter, then placed in an undesired site.Therefore, the filter was retrieved with a snare device.The physician considered to replace the filter though, he decided to abandon filter placement itself due to the amount of thrombus and its location.The procedure was finished without placing the filter.The jugular introducer was returned for device evaluation.Per device evaluation: the jugular introducer was curved, and the red safety button was pressed down.No damage was observed on the sheath tip.It was observed that the grasping hook has been straightened.A test filter could be attached and detached from the jugular introducer, but the straightened grasping hook did not grasp the filter hook completely.The cause for the reported failure cannot be determined, based on the device evaluation.The observation that the grasping hook has been straightened is seen before, if the filter is pulled back during attempts to resheath it.According to the instruction for use excessive force should not be exerted in placement of the filter and ifu also describes: if the filter is not in the desired position, carefully advance the introducer sheath over the filter until right before the anchors.Reposition the system as desired, and again withdraw the introducer sheath and protection sheath until the protection sheath and jugular introducer handle are in contact with one another, completely exposing the filter.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before final inspection, 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.

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
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 14367257
• MDR Text Key: 291484872
• Report Number: 3002808486-2022-00312
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)241006(10)E4167887
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E4167887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2021
• 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
• Patient Outcome(s): Required Intervention