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

Catalog Number IGTCFS-65-1-JUG-CELECT-PT

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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: i was notified by a physician, that he tried to deploy a jugular celect filter.After pushing the release button several times, it was unable to unhook after many attempts.They had to cut the sheath to get it out.They used another filter and it worked fine.Patient was fine.Patient outcome: 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

Manufacturer ref# (b)(4).Summary of investigational findings: it was reported that when the physician tried to deploy the filter it would not release even after several attempt pushing the release button.The physician had to cut the sheath to get the device out.Another device was used instead.The patient was fine after.Cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.According to the instruction for use excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.There are adequate controls in place to ensure that this type of device is manufactured to specifications.Based on the provided information it is unknown what caused the filter to be unable to release from the jugular introducer.However, excessive tension during deployment may have prevented the filter being released from the introducer.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 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: 11892023
• MDR Text Key: 261822865
• Report Number: 3002808486-2021-01281
• Device Sequence Number: 1
• Product Code: DTK
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1