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

Catalog Number IGTCFS-65-1-UNI-CELECT-PT

Device Problems Material Puncture/Hole (1504); Patient-Device Incompatibility (2682); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-1-uni-celect-pt (b)(4).Summary of investigational findings: evaluation is based on the description and the investigation on the returned blue sheath.The blue sheath is returned for investigation; "a penetration located approx.12 mm from the distal end of the sheath.Several kinks/bends of the sheath are found in the area approx.7 cm from the distal end.Furthermore, there are two kinks, which presumable are from advancement of the filter introducer into the sheath.It is most likely that the penetration is due to the tortuous anatomy noted in the event description".The root cause for the advancement difficulties is most likely the reported tortuous anatomy.Under normal conditions the sheath is strong enough to accomplish the procedure, but it may kink if advanced through e.G.Tortuous anatomy and the filter may be prone to exit the sheath wall if advanced through a kinked sheath.Reference is made to the ifu: "warning: excessive force should not be exerted to advance the filter through the delivery system." there is found no evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: during an ivc filter placement, the physician felt resistance trying to advance filter in sheath.Retrieved the sheath and opened another filter.The physician could not use the left femoral artery due to trauma.Used the right femoral approach and anatomy was tortuous.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.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET 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: 5899275
• MDR Text Key: 52848484
• Report Number: 3002808486-2016-00949
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)170909(10)E3253689
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2014
• 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