MAUDE Adverse Event Report: WILLIAM COOK EUROPE 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 10/27/2021

Event Type  malfunction  

Event Description

Description of event according to initial reporter: the access was gained from the right jugular artery.The target site was inferior vena cava (ivc).When the physician tried to retract the filter into the sheath because it was tilted (due to the tortuosity in the ivc after deployment of the ivc filter), the filter was released without (before) pushing the red safety lock button the filter function seemed to be unaffected, so the filter was placed in place.The tilt was not eliminated(resolved), but the doctor decided that the tilt was within the acceptable range for the function of the ivc filter, so he left the filter in place (with the tilt) and finished the procedure.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.

Manufacturer Narrative

(b)(4).Similar to device marketed under pma/510(k): k172557.Investigation is still in progress.

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: it was reported that the filter still connected to the introducer was tilted due to the tortuosity in the ivc.The physician tried to retract the filter into the sheath after the observed tilt, but the filter was released without activate the release mechanism.The filter tilt was not resolved but the physician decided that the filter tilt was within the acceptable range, so the filter was left in the patient and procedure was completed.Jugular introducer, coaxial introducer system and pre-dilator was returned for device evaluation.Introducer was curved but without any other nonconformances.The jugular introducer was a bit curved, and the red safety button was not pressed down.The grasping hook was a bit straightened.A test filter was used to show it was possible to attach and detach the filter.Introducer sheath had an indentation at the tip.The indentation seen on the introducer sheath and the grasping hook being straightened was likely due to the retraction of a tilted filter.The instruction for use clearly describe how to carefully advance the introducer sheath over the filter if it is not in the desired position.Based on the provided information and device evaluation a likely cause for this event was that the filter released due to force applied by the physician in attempt to retract the filter into the introducer sheath, which resulted in the straightened grasping hook, thus being unable to maintain the filter on the introducer.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.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
• 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: 12850761
• MDR Text Key: 286467499
• Report Number: 3002808486-2021-01967
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)240308(10)E4082859
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2024
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E4082859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2021
• 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 Age: 90 YR
• Patient Sex: Female