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

Catalog Number IGTCFS-65-2-JUG-CELECT-PT

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Similar to device under pma/510(k) k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: physician mentioned that it took 4 attempts to release the ivc filter when ready to deploy.Had released safety button then deployment button in recommended sequence.No adverse effects was reported on the patient 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: it took 4 attempts to release the ivc filter when ready to deploy.Had released safety button then deployment button in recommended sequence.No adverse effects to the patient have been reported.According to instruction for use excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.Based on the provided information it is unknown why the filter was prevented from being released.However, a possible cause is excessive tension during deployment prevented the filter from being released in first attempt.There are adequate controls in place to ensure the device was manufactured 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 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: 10262952
• MDR Text Key: 200046580
• Report Number: 3002808486-2020-00709
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343105
• UDI-Public: (01)10827002343105(17)221031(10)E3916408
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: IGTCFS-65-2-JUG-CELECT-PT
• Device Lot Number: E3916408
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1