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 Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturers ref# (b)(4).Pma/510(k) k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the outer sheath had a kink or hole where the hub meets the blue outer sheath.The dilator was difficult to get through the hub but eventually it went through and inserted into the patient.The filter was still deployed and was deployed successfully.The final picture of the filter placement was unsuccessful as the contrast was leaking out of the hole where the hub meets the blue outer sheath.Procedure was completed successfully.Additional information received 12mar2020: filter was placed just fine.No tilt.Patient outcome: patient does have dvt.Patient was not effected at all.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the outer sheath had a kink or hole where the hub meets the blue outer sheath.The dilator was difficult to get through the hub but eventually it went through and inserted into the patient.The filter was still deployed and was deployed successfully.The final picture of the filter placement was unsuccessful as the contrast was leaking out of the hole where the hub meets the blue outer sheath.Procedure was completed successfully.Introducer sheath and three-way stopcock was provided for product evaluation.The introducer sheath has several kinks and there was a hole near the hub.The valve was without any nonconformances.It was easy to get an introducer dilator through the valve.Per the product evaluation, the likely cause is that a tortuous anatomy and excessive force contributed to the experienced event.According to instruction for use under preparation, advance the introducer dilator through the middle of the check-flo valve on the introducer sheath.Secure the introducer dilator to the introducer sheath by twisting the dilator hub clockwise until a click is felt.Based on the provided information and product evaluation an exact cause is unknown, however it seems in the description of event that the dilator was used after the first attempt to advance the introducer sheath.This could contribute to the reported event.No evidence to suggest that the device is not manufactured according to specification.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: 9851828
• MDR Text Key: 184058653
• Report Number: 3002808486-2020-00332
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)230107(10)E3937936
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2023
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3937936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR