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

Catalog Number IGTCFS-65-1-FEM-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).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "when the physician deployed it, one of the legs did not deploy; therefore, the entire filter was slightly maladjusted and tilted.Patient has a cervical collar that cannot be taken off to remove the filter ((b)(4)).His colleagues said they have had that issue before, but nobody has told the md ((b)(4))"."spoke to md who said it happened to her before but with a little ¿jiggling¿ it freed up".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.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).Name and address for importer site: cook medical incorporated (cmi) (b)(4).Registration no.: (b)(4).Ec method code: 4109 - historical data analysis.4114 - device not returned.Ec conclusion code: 4315 - cause not established.Summary of investigational findings: no product was returned and no imaging was provided to support the investigation.Therefore, it would be inappropriate to speculate at what may or may not have caused the difficulties encountered, when attempting to deploy the filter, unless they were due to incompatibilities between the introducer sheath and the femoral introducer.Said incompatibility issue was eliminated as of 19jun2018 by internal actions verifying proper compatibility between femoral introducer and sheath.No evidence to suggest product was not manufactured to specifications.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 FEMORAL 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: 7713431
• MDR Text Key: 114820478
• Report Number: 3002808486-2018-00823
• Device Sequence Number: 1
• Product Code: DTK
• 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: 09/28/2018

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 Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/05/2018
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1