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

Model Number G52917

Device Problems Difficult to Insert (1316); Difficult or Delayed Activation (2577)

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

Event Date 11/09/2022

Event Type  Injury  

Event Description

Description of event according to initial reporter: the customer stated that they accessed through the groin and upon deployment they hit the safety blue button, filter wouldn't release, but when it did it released in the sheath.In delivery they had to advance the cannula to push filter out of sheath.Filter was placed lower than expected, but no harm to patient.Explant date is tbd (to be determined).Rep will be sending in a video for this complaint.Patient outcome: the patient did not require any additional procedures due to this occurrence.

Manufacturer Narrative

Manufacturer ref#: (b)(4).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.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: when the physician hit the blue release button the filter wouldn't release.The filter ended up being released in the sheath.The filter was pushed out of the sheath and was placed lower than expected, but no harm to the patient reported.According to the instruction for use verify that the introducer sheath hub and femoral introducer handle are connected to ensure that the femoral cup is completely free of the introducer sheath before filter release.There are adequate controls in place to ensure the device was manufactured to specifications.Despite multiple attempts to receive the device, it was not returned for investigation.Based on the provided information it is assumed that the physician unintendedly attempted to deploy the filter inside the introducer sheath.The ifu clearly specify how to ensure proper filter release.If the filter was placed in an undesired location it is recommended that the filter should be retrieved.No evidence to suggest that the device is not manufactured according to specification.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 FEMORAL 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: 15902787
• MDR Text Key: 304685486
• Report Number: 3002808486-2022-01040
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529172
• UDI-Public: (01)10827002529172(17)250113(10)E4209499
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G52917
• Device Catalogue Number: IGTCFS-65-1-FEM-TULIP
• Device Lot Number: E4209499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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): Required Intervention