MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-2-UNI-CELECT

Device Problems Failure to Advance (2524); Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2016

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).Catalog number: igtcfs-65-2-uni-celect.Similar to device with 510(k) k090140.Investigation is still in progress.

Event Description

Description of event according to complainant: the reporter said that the surgeon began to advance the filter after the sheath was placed into the desired position through the left femoral vein.The device gained the resistance when advancing through the angle place between the left common iliac vein and inferior vena.It then failed to go through and was withdrew back.The filter was found distorted after withdrawing it.Additional information received on may12,2016: the surgery stopped when issue happened.The second surgery date is (b)(6) 2016.Then the surgeon implanted through jugular vein and finished the operation successfully.Patient outcome: the patient is well and did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-2-uni-celect.Similar to device with 510(k) k090140.Summary of investigational findings: the femoral introducer with loaded filter, the blue sheath, the long dilator, and the jugular introducer were returned.The red locking mechanism is pressed/unlocked.Approx.22cm of the distal end of the blue sheath is slightly curved and also, the sheath is kinked approx.8.2 and 10.3cm from the tip, as if filter legs were about to penetrate the sheath wall.Two secondary filter legs are out of shape - probably a consequence of pulling the filter back through the check-flo valve when the introducer "was withdrew back".These findings were probably caused by the reported resistance when attempting to advance the sheath "through the angle place between the left common iliac vein and inferior vena." under normal conditions the introducer sheath is strong enough to accomplish the procedure, but it may kink if advanced through tortuous anatomy and the filter legs may be prone to exceed the sheath wall if advanced through a kinked sheath.To address the issue, the ifu states that excessive force should not be used to place the filter.It is noted that a filter was placed through jugular vein and that the patient did not experience any adverse effects due to this occurrence.Investigation found no evidence to suggest product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: the reporter said that the surgeon began to advance the filter after the sheath was placed into the desired position through the left femoral vein.The device gained the resistance when advancing through the angle place between the left common iliac vein and inferior vena.It then failed to go through and was withdrew back.The filter was found distorted after withdrawing it.Additional information received on may 12,2016: the surgery stopped when issue happened.The second surgery date is (b)(6) 2016.Then the surgeon implanted through jugular vein and finished the operation successfully.Patient outcome: the patient is well and did not experience any adverse effects due to this occurrence.

• Brand Name: COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS
• 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: 5694120
• MDR Text Key: 46366804
• Report Number: 3002808486-2016-00364
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529219
• UDI-Public: (01)10827002529219(17)181216(10)E3397422
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2016

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-65-2-UNI-CELECT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 06/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2015
• 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): Required Intervention
• Patient Age: 79 YR