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

Model Number G34502

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: ivc filter placement procedure.Product prepared per normal protocol.Advanced filter into sheath and then it became stuck; could not advance or remove filter cannula.Removed whole system and restarted with new set.Defective g34502 lot# e3959079 part of device was saved for return.Patient outcome: no harm to patient.

Manufacturer Narrative

Manufacturers ref#: (b)(4).Summary of investigational findings: the investigation is based on the event description and an evaluation of the returned product.It was reported that the filter stuck inside the sheath, why the sheath and the filter were removed and replaced without any harm to the patient.The proximal 11cm of the sheath was returned with the valve still attached and with the filter sticking inside.A kink was noted in the sheath approx.2cm from the hub and since the filter could not pass the kink, the hub was opened and the filter was removed from the sheath.After opening the hub the cup of the femoral introducer with the primary filter legs loaded inside was found placed inside the valve, but could easily be advanced and therefore, it is suggested that the kink in the sheath caused the reported difficulties in advancing the filter.Under normal conditions the sheath is strong enough to accomplish the procedure, but it may kink if advanced through tortuous anatomy and according to the instructions for use excessive force should not be used to place the filter.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because no non-conformances 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.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: COOK CELECT PLATINUM 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
• MDR Report Key: 10090469
• MDR Text Key: 198297978
• Report Number: 3002808486-2020-00560
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)230303(10)E3959079
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2023
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3959079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 09/07/2020
• Supplement Dates FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1