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 Material Deformation (2976)

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

Event Type  Injury  

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: "upon deployment the physician noticed that one of the legs was not shaped properly.Before the device was deployed it was removed from the patient.The physician elected to use a competitors device to complete the intended procedure.An "aln filter" was used to complete the procedure." patient outcome: according to initial reporter, the patient did not experience adverse effects due to this occurence.

Manufacturer Narrative

(b)(4).Summary of investigational findings: no product was returned and no imaging was provided.Based on the limited information provided it would be inappropriate to speculate at what may or may not have occurred via the note stating "upon deployment the physician noticed that one of the legs was not shaped properly.Before the device was deployed it was removed from the patient." since a femoral approach it is unknown, how the misshapen leg was discovered and how the filter was removed from the patient.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: "upon deployment the physician noticed that one of the legs was not shaped properly.Before the device was deployed it was removed from the patient.The physician elected to use a competitor's device to complete the intended procedure.An "aln filter" was used to complete the procedure." patient outcome: according to initial reporter, the patient did not experience adverse effects due to this occurence.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6180030
• MDR Text Key: 62527350
• Report Number: 3002808486-2016-01494
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)190913(10)E3493552
• 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: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Date Device Manufactured: 09/13/2016
• 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
• Patient Outcome(s): Required Intervention