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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Pma/510(k): k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: a patient of undisclosed gender and age underwent a vena cava filter placement in which the cook celect platinum navalign femoral vena cava filter set, (b)(4) , was used.The medical staff tried to load the filter in to the hub of the celect device.The filter would not go in the hub.It just stopped.It would not advance to be loaded.They opened a different box, same g#, and it loaded perfectly fine.The case was completed.Patient outcome: the patient did not require any additional procedures due to this occurrence.Prior to patient contact.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: they tried to load the filter into the hub of the celect device.The filter would not go in the hub.It just stopped.It would not advance to be loaded.They opened a different device and completed the procedure successfully.Femoral introducer, introducer sheath and celect-pt filter was returned for product evaluation.Per product evaluation: it was possible to advance the filter without any observed nonconformance the filter was without any observed nonconformance.It was possible to get the femoral introducer through the hub with the check-flo valve, and the hook of the filter.There was a slot in the valve.The cause for the reported failure cannot be determined, based on the product evaluation.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, 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.According to the instruction for use do not exert excessive force to advance the filter through the introducer system.There are adequate controls in place to ensure the device was manufactured to specifications.Based on the provided information and returned product it is unknown what caused the femoral introducers inability to be inserted into the introducer sheath.However, during manufacturing if the femoral introducer cannot be advanced through the introducer sheath it would be destroyed.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: 11441512
• MDR Text Key: 247001567
• Report Number: 3002808486-2021-00927
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)230806(10)E4004791
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2023
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E4004791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1