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

Model Number G52916

Device Problem Difficult to Advance (2920)

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

Event Date 06/08/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturers ref# (b)(4).Similar to device marketed under k211874.Summary of investigational findings: during angiography it was discovered that the sheath had kinked approx.15cm from the hub and that blood leaked from the kink.Another sheath was used to complete the procedure.The coaxial introducer system was returned and an investigation of the sheath revealed a penetration 513mm from the distal end and a kink at the back of the penetration.The penetration seemed to start from inside and was likely caused by a filter leg.Based on these findings and the information provided the exact reason for the penetration cannot be determined, but the sheath may kink if advanced through tortuous anatomy and the filter may be prone to exceed the sheath wall, if advanced through a kinked sheath.The instructions for use supplied with the device warn that excessive force should not be exerted to advance the filter through the delivery system and specify in detail how to advance the filter with the filter introducer into the introducer sheath and following how to connect the components to position the filter at the radiopaque band of the introducer sheath before the sheath is withdrawn and the filter is released.There are adequate controls in place to ensure that this device is manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, 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 21cfr 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: for clots prevention purpose prior to planned surgery, ivc filter placement procedure was performed.The user inserted the introducer sheath from the right jugular vein.Then he performed angiography and during angiography, he found a kink in the sheath and blood leakage from the kinked site.It was approx.15cm from the hub.So he opened another one to replace the sheath to complete the procedure.Patient outcome: the patient did not experience any adverse effects due to this occurrence.

• 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: 15368340
• MDR Text Key: 304923124
• Report Number: 3002808486-2022-00939
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)241126(10)E4191918
• Combination Product (y/n): N
• 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
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• 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: E4191918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2021
• 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