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

Model Number G34309

Device Problem Difficult to Advance (2920)

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

Event Date 01/08/2021

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: filter delivery system punctured side of stent when being inserted.Sheath and filter had to be replaced.New kit opened.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

Manufacturer ref# (b)(4).Summary of investigational findings: the delivery system punctured delivery sheath outside the patient.Sheath and filter were replaced.No reported harm to the patient.The protection sheath was returned with the locked jugular introducer and the unloaded celect-pt filter inside and so was the blue sheath with the dilator inside.The protection sheath with the jugular introducer was kinked 55mm from distal tip and a dent was noted in the most distal tip.In the blue sheath a penetration was noted close to the hub 55mm from the hub entrance, ie in the area of the anchors of the primary filter legs and the most distal tip of the protection sheath/introducer, when advanced through the sheath valve.A thorough investigation did not reveal any non-conformances in any of the devices and the filter could be loaded and detached without difficulties and consequently the reason for the detached filter cannot be determined.Also, based on the limited information provided and the investigation findings the exact reason for the punctured sheath cannot be determined, but due to the area of the penetration and comparing it to the distance between the kink and the most distal tip of the protection sheath, it is suggested that the sheath was somehow kinked during advancement.Under normal conditions the sheath is strong enough to accomplish the procedure, but is may kink if advanced through tortuous anatomy and the filter legs may be prone to exceed the sheath wall if advanced through a kinked sheath.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, 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 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.

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 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: 11450011
• MDR Text Key: 244158843
• Report Number: 3002808486-2021-00935
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)230907(10)E4015446
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2023
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E4015446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1