MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G34505

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Occupation: lead radiology tech.Pma/510k: pma/510(k) k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the filter deployment system would not pass through the valve of the sheath.A second filter deployment system was opened and placed through the first sheath with no issue.The procedure was successfully completed with the second device.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects 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

Manufacturers ref# (b)(4).Summary of investigational findings: the introducer would not pass through the valve of the introducer sheath.A second filter set was opened, and the introducer system was advanced through the first sheath with no difficulty.The procedure was therefore completed successfully with the second device, and no adverse effects on the patient was reported due to this occurrence.A wrinkled celect-pt filter and a filter protection tube was returned and evaluated in the complaint investigation.Two of the secondary legs was wrinkled around the top of the filter, and most of the secondary legs was bended in some matter.Measurements of the secondary filter legs was not executed due to their damages.However, the diameter of the primary legs was measured to be in accordance to specifications.No introducer or sheath was returned with the filter, and it is not clear in the event description whether femoral or jugular approach was used.However, the condition of the secondary filter legs suggest that the femoral filter introducer was used for the procedure, as the filter is loaded with the primary filter legs on the femoral introducer, and the secondary filter legs are therefore expanded.The exact cause for why the user could not advance the filter introducer through the introducer sheath is unknown.However, it is very unlikely that a filter with such damage could pass quality control at wce, since there are adequate controls in place to ensure the device was manufactured to specifications.It is more likely that the filter got damage during the procedure by for instance excessive force or rotation of filter inside the introducer system, which could have led to difficulty in advancing the introducer with the filter through the introducer sheath.Ifu warns not to rotate the preloaded filter inside the introducer system, and not to exert excessive force in placement of filter.The device history record was reviewed with no evidence to suggest that the 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.

• Brand Name: COOK CELECT PLATINUM NAVALIGN UNISET 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: 9068983
• MDR Text Key: 158640803
• Report Number: 3002808486-2019-01482
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)220429(10)E3847268
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2022
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3847268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1