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 Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.(b)(4).Investigation is still in progress.

Event Description

"could not advance the contained filter though the diaphragm.The filter legs were out of the sheath.For safety purposes, they exchanged out everything." according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of (b)(6) (importer).Manufacturers ref# (b)(4).G1) name and address for importer site: (b)(6).Registration no.: (b)(4).Summary of investigational findings: investigation is based on event description and returned device.The jugular introducer with loaded filter could not be advanced through the sheath, as the filter legs were outside the protection sheath.The device was removed and replaced with no harm to the patient.Only the inner sheath with jugular introducer inside was returned.The filter was still loaded to the introducer and inside the sheath with only the clean anchors of the primary legs extending from the sheath.On the introducer handle the safety button was not pressed, ie the system was still locked and a kink was noted approx.51mm from the distal sheath tip, ie just where the filter hook is placed inside.Also, the sheath and introducer were bent almost perpendicularly close to the shells of the sheath.Based on these findings the exact reason for the difficulties encountered when attempting to advance the introducer with the filter cannot be determined, but the anchors sticking out of the sheath are not supposed to have caused them.However, the inner sheath and the introducer may have been somehow damaged, when advanced through the sheath valve, but this is only speculation since the introducer sheath was not returned.No evidence to suggest that this device was not manufactured according 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.

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
• MDR Report Key: 8211698
• MDR Text Key: 131904652
• Report Number: 3002808486-2018-01539
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)210910(10)E3771326
• Combination Product (y/n): N
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2021
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E3771326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Distributor Facility Aware Date: 12/10/2018
• Device Age: 3 MO
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1