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

Model Number G34502

Device Problem Positioning Failure (1158)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: "the filter would not release upon deployment.A new g34502-igtcfs-65-1-fem-celect-pt was opened and used to complete the procedure." patient outcome: patient did not require any additional procedures or adverse effects on the patient due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description and returned product.Only the femoral introducer with loaded filter was returned.One of the secondary filter legs was wrinkled and another was squeezed under a third secondary leg.The filter hook was straightened.On the femoral introducer the locking mechanism was not pressed, ie the system was still locked, but after unlocking it worked as intended and the filter released without difficulty.The locked system may have been the reason for the filter to "not release upon deployment" and probably retrieving the filter through the sheath and the valve may have damaged the filter and misplaced the filter legs.The reason for the straightened filter hook cannot be determined, unless a loop device was placed via jugular approach and attempts were made to release the filter by pulling it from there.It is noted that the patient experienced no adverse effects and that another filter was placed.Ifu: when the filter position is correct, push the red safety button to prepare filter release.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 FEMORAL 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: 6953907
• MDR Text Key: 90258841
• Report Number: 3002808486-2017-01975
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)200711(10)E3607288
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/22/2017
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2017
• 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