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 Kinked (1339)

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

Event Date 08/07/2017

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: they put the filter in and then went to move it a little bit and the secondary struts prolapsed.The device was removed and they put in a second one.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).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description and returned device.The femoral introducer with loaded celect-pt filter was attached and an investigation found one of the secondary filter legs bending upwards in the direction of the filter hook.This type of damage combined with the fact that the filter was moved "a little bit" clearly indicates that attempts were made to move the pre-expanded filter downwards.According to the ifu, repositioning is possible only by advancing the filter; retracting the filter could damage the secondary legs or the caval wall.No evidence to suggest that this filter device was not manufactured according to specifications and nothing indicates that it did not perform as intended.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: 6840916
• MDR Text Key: 84987462
• Report Number: 3002808486-2017-01746
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)191114(10)E3519245
• 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,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

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 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: 08/08/2017
• Device Age: 9 MO
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 09/04/2017
• Supplement Dates Manufacturer Received: 11/17/2017
• Supplement Dates FDA Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2016
• 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