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 10/14/2022

Event Type  Injury  

Manufacturer Narrative

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

Description of event according to initial reporter: selected navalign and approached from jugular vein.When the physician was to pull the filter into the catheter for reposition, the filter released without pushing even the safety button.He retrieved it with gtrs-200-rb (lot #e4194406) and replace another navalign.Patient outcome: the complainant did not report any adverse effects to the patient 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

Manufacturer ref# (b)(4).Summary of investigational findings: it was reported that during attempt to repositioning the filter it was pre-released.The filter was released without pushing the safety button.The physician retrieved the filter with a gtrs and placed another filter instead to complete the procedure successfully.Two jugular introducers (referred to as a and b respectively), introducer sheath, tulip filter, introducer dilator and a blue retrieval sheath from gtrs were returned for device evaluation.The filter was observed with a lot of blood/biological matter.There were no nonconformance's observed on the filter hook.The leaves were a bit small which could have occurred because they were fixed in blood/biological matter.Jugular introducer (a) was curved and had a kink.The red safety button was observed to not have been pressed down.The red safety button was then pressed, and it was not possible to get the grasping hook out, but after the jugular introducer had been soaked it was possible to get the grasping hook out.It was observed that the grasping hook had been pulled out of shape.It was possible to attach and detach a filter but due to the grasping hook had been pulled out of shape, the grasping hook could not cover the filter hook completely.Jugular introducer (b) was curved and had the red safety button pressed down.No nonconformance's observed.It was possible to attach and detach a filter.Introducer sheath were without any observed nonconformance's.Introducer dilator from the tulip device was returned inside the blue retrieval sheath from a gtrs device.The introducer dilator was observed curved but without any other nonconformance's.The blue retrieval sheath was curved and had several kinks.There was observed an indentation in the tip of the sheath.The cause for the reported failure cannot be determined, based on the device evaluation.However, the grasping hook was pulled out of shape which could occur if excessive force was used to reposition the filter.It was assessed that because no non-conformance's 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.According to the instruction for use excessive force should not be exerted to reposition or retrieve the filter, as it may lead to filter breakage and/or harm to the patient.There are adequate controls in place to ensure the device was manufactured to specifications.Based on the on the provided information and device evaluation an exact cause for this event cannot be determined.However, the observation of the grasping hook on the jugular introducer which have been pulled out of shape could indicate that excessive force was used during repositioning of the filter.If excessive force was used during repositioning it is possible the filter was pre-released during this attempt due to the filter was not completely covered by the grasping hook, but this is purely speculation.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: 15637172
• MDR Text Key: 302056812
• Report Number: 3002808486-2022-00996
• Device Sequence Number: 1
• Product Code: DTK
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• 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: E4297789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• 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): Hospitalization