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

Model Number G34502

Device Problems Improper or Incorrect Procedure or Method (2017); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: phone conversation: the physician got it out, but one of the upper/secondary struts looked like it was titled and sticking out.The physician pulled it back into the sheath and inverted the umbrella.A new filter was opened and used to complete the intended procedure.Patient outcome.The complainant did not report any adverse effects to the patient due to this occurrence.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the physician got it out, but one of the upper/secondary struts looked like it was titled and sticking out.The physician pulled it back into the sheath and inverted the umbrella.A new filter was opened and used to complete the intended procedure.Based on the provided information it is unknown what have caused the secondary leg to stick out before the physician decided to retract the filter.However, it is stated in the instruction for use that secondary legs could be damaged if it is attempted to be retracted inside the introducer.According to instruction for use attempting to retract the filter at this point of the deployment sequence could damage the secondary legs or caval wall.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 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

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: 10360673
• MDR Text Key: 201509859
• Report Number: 3002808486-2020-00736
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)230423(10)E3977444
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2023
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3977444
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening