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

Catalog Number IGTCFS-65-1-JUG-CELECT-PT

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-1-jug-celect-pt.Name and address for importer site: (b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: filter that, when unsheathed, legs were overlapped.It was withdrawn and another filter used.After the filter was sheathed and removed they opened the filter on the back table and it was fine.Patient outcome: no adverse effects on the patient was reported due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Manufacturers ref# (b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description and returned product.The jugular introducer and the filter were returned.The filter had detached, but was properly expanded and without any damages.However, no images were provided and therefore it would be inappropriate to speculate at what may or may not have caused the filter legs to overlap, when the filter was unsheathed, but reference is made to ifu, warning not to rotate the released filter inside the vena cava.Doing so may compromise the performance of the filter.During the manufacturing/qc processes the spring effect of every filter is 100 % controlled, as they are all deployed after advancement through a testing sheath.There is no evidence to suggest that this device was not manufactured according to specifications.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
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 7058380
• MDR Text Key: 93571946
• Report Number: 3002808486-2017-02291
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• 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: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/08/2017
• Date Manufacturer Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1