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 Problems Positioning Failure (1158); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description of event according to complainant: the filter was partially unsheathed and would not continue to unsheath properly or re-sheath.The user had to deploy the filter in an unintended target site due to sheathing difficulties and retrieve the filter.The complaint device and filter were removed and the procedure was completed using another of the same device.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Date of event: unknown as information was not provided.Catalog#: igtcfs-65-1-fem-celect-pt.(b)(4).Summary of investigational findings: returned product is the replacement device, not the complaint device.Complaint device is not available for return and product investigation can thus not be performed.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended.The event description mentions that the filter couldn't be resheated properly, but this must not be attempted.The ifu warns that repositioning is possible only by advancing the filter and that retraction of the filter could damage the secondary filter legs or the caval wall.It is noted that the event did not harm the patient and that the procedure was completed successfully using a new device.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: the filter was partially unsheathed and would not continue to unsheath properly or re-sheath.The user had to deploy the filter in an unintended target site due to sheathing difficulties and retrieve the filter.The complaint device and filter were removed and the procedure was completed using another of the same device.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 5642964
• MDR Text Key: 46214472
• Report Number: 3002808486-2016-00255
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)180625(10)E3342569
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• 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): Other