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 Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2012

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog # igtcfs-65-2-uni-celect.Similar to device under 510(k) k090140.Summary of investigational findings: the investigation is based on event description(s) and provided imaging.In imaging review of event, the filter configuration post-deployment indicates that the filter was deployed in a narrow ivc.No indications of perforation of ivc with the filter hook, since images show no obvious signs of extravasation.Images also indicate that the filter was pulled back into the sheath since the secondary filter legs are completely damaged and curled up around the filter hook.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: filter was advanced but it perforated the ivc wall.Patient outcome: unknown.

• 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: 5902790
• MDR Text Key: 52947745
• Report Number: 3002808486-2016-00983
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529219
• UDI-Public: (01)10827002529219(17)141027(10)E2822932
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 03/06/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2012
• Date Device Manufactured: 10/01/2011
• 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