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

Model Number G34309

Device Problems Material Protrusion/Extrusion (2979); Torn Material (3024); Device Handling Problem (3265)

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

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-1-jug-celect-pt.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "they were trying to insert the jugular ivc filter into the subclavian vein and in doing so they could not get the filter to track around the turn correctly.The filter split the side of the deployment system.It split the internal deployment system and the blue external sheath.They withdrew the filter and put in a ivc filter from another manufacturer." 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

Exemption number e2016032.(b)(4).Summary of investigational findings: investigation is based on event description and returned product.The jugular introducer with loaded filter and the blue sheath were returned.Several kinks were noted on the sheath between 22cm and 26.5cm from the fitting.Two penetrations were noted in a severe kink approx.32cm from the fitting.The introducer sheath was kink in the area, where the filter is attached to the introducer.No damages were noted on the filter.Based on these findings combined with the report stating that attempts were made to advance the device into the subclavian vein, it is suggested that the device was exposed to manipulation beyond its intended design.The filter is intended for placement via a jugular vein and it is noted that the customer was advised of the off label use.Under normal conditions the introducer sheath is strong enough to accomplish the procedure, but it may kink if excessive force is used to advance it through tortuous anatomy and the filter may be prone to exceed the sheath wall if advanced through a kinked sheath.Ifu, intended use: the product is intended for percutaneous placement via a jugular vein for filtration of inferior vena cava (ivc) blood to prevent pe.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that tit did not perform as intended.Cook medical will continue to monitor for similar events.

• 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: 7159482
• MDR Text Key: 96477911
• Report Number: 3002808486-2017-02541
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)200420(10)E3575658
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/07/2017
• Device Age: 8 MO
• Date Manufacturer Received: 02/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1