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

Model Number G34505

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: the filter would not pass through the sheath.A new igtcfs-65-1-uni-celect-pt from the same lot number was opened and used to complete the procedure.Patient outcome: the patient did not require any additional procedures due to this occurrence.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

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of (b)(6) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: (b)(6).Registration no.: (b)(4).Summary of investigational findings: the filter would not pass through the sheath.The procedure was completed with another device without any adverse effects to patient.The sheath and the femoral introducer with loaded filter were returned.Both were curved, probably to fit into a small plastic pouch for return.The filter was returned inside the protection tube, but after removing the tube some of the secondary filter legs were found not evenly distributed and one of them crossed its primary leg.However, the slightly misplaced secondary filter legs do not explain "the filter would not pass through the sheath", as removal of the filter from the sheath through the valve, would have caused severe damage to the secondary filter legs bending them upwards and not only a misplacement.During investigation the curved femoral introducer with the filter could be advanced through the curved sheath without any resistance and based on these findings the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory and consequently the exact reason for the reported difficulties encountered cannot be determined.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.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 UNISET 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: 8225473
• MDR Text Key: 133351518
• Report Number: 3002808486-2019-00019
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)211002(10)E3780330
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2021
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3780330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Distributor Facility Aware Date: 12/17/2018
• Device Age: 2 MO
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1