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

Catalog Number IGTCFS-65-UNI-CELECT

Device Problems Failure to Capture (1081); Malposition of Device (2616)

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

Event Date 05/25/2011

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot#: unknown as information was not provided.Catalog#: igtcfs-65-uni-celect expiration date: unknown as lot# is unknown.Similar to device under 510(k) k073374.(b)(4).Summary of investigational findings: available images from deployment confirm that the filter placement looked normal.But the images also confirm that the filter had tilted 14 days after placement.However, filter configuration is normal.It was not possible to cover the filter completely with the inner and outer sheath of the gtrs-200-rb, since the filter legs were attached to the vena cava wall.Imaging from retrieval attempt show that the filter collapsed partly.Most likely the physician twisted the gtrs-200-rb during the retrieval attempt and thereby the filter legs got entangled and stayed collapsed when gtrs-200-rb was removed.Tilt is considered as a well known risk, which is described in the scientific literature.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: ivc filter was placed on (b)(6) 2011.Ct scan on (b)(6) 2011 showed ivc filter tilted 30 degrees from insertion date.Retrieval of the ivc filter was attempted on (b)(6) 2011 without success.The filter legs had imbedded in the wall and would not release when snared and pulled on with gtrs-200-rb.Patient outcome: the celect ivc filter was left in the ivc as it wasn't retrievable.No adverse effects to the patient were reported.

• Brand Name: COOK CELECT FEMORAL & JUGULAR 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: 5895667
• MDR Text Key: 52727481
• Report Number: 3002808486-2016-00912
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 05/30/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-UNI-CELECT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 52