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 Difficult to Advance (2920); Activation Failure (3270)

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

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Pma/510(k) k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: a patient of unknown age and gender underwent a filter placement in which the celect platinum navalign femoral vena cava filter set, g34502, was used.The staff loaded the filter in the device hook first.It felt tight and when they [medical staff] pulled the hook out it was straight.The rest of the device was retrieved and another celect platinum device was 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.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: based on the event description, it is assumed that the medical staff loaded the femoral filter introducer with the filter into the introducer sheath, where they met resistance and could not advance the filter.The medical staff pulled therefore the introducer with the filter out and the hook, which is assumed to be a hook of a secondary filter leg, was straight.The procedure was completed with a new set of the same type device.No adverse effects on the patient have been reported due to this occurrence the complaint device was not returned and no photos are available.It is was therefore not possible to conduct a device failure analysis for this investigation.A kinked introducer sheath can lead to difficulty in advancement of filter introducer through the sheath, however, it is unknown if the sheath of the complaint device was kinked.Furthermore, ifu states that the preloaded filter should not be rotated inside the introducer system, and that excessive force should not be exerted to advance the filter through the introducer system.It could be possible that the user exerted excessive force and rotated the preloaded filter inside the introducer, when resistance was met, which could have led to the reported event where the hook straightened.However, this is not clear or described in the event description, and the cause for the reported event can therefore not be established due to insufficient/limited information.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because no non-conformances were detected, 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.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 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: 8904984
• MDR Text Key: 158868342
• Report Number: 3002808486-2019-01222
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)220508(10)E3850983
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2022
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3850983
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1