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 08/04/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-2-uni-celect.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: femoral and jugular introducer returned.Filter attached to grasping hook of jugular introducer and approx.3mm of primary legs jut out of the protection sheath.The red locking mechanism is pushed.Protection sheath kinked where filter is attached to the introducer, but still filter can easily be advanced and deployed from grasping hook.Based on these findings the exact reason for the deployment difficulties cannot be determined, but it is known from the literature that excessive back tension could result in deployment difficulties/failure when pressing the release button.It is stated in the ifu that: "while keeping slight back tension on the introducer push the release button completely to ensure proper release of the filter.Repositioning of the filter is no longer possible.The filter is now released." and "excessive tension during deployment may prevent the filter from releasing when release mechanism is activated." cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: as per complaint form: right jugular approach, customer using uniset so had to switch device from femoral to jugular (they have done this many times before).Access gained and device inserted, when the consultant dr tried to release the filter from the delivery system it would not release.Several attempts made and then the filter was re-sheathed and the delivery system was removed.A new device was opened (from the same lot number) and deployed no problems.This incident did not lead to any patient complications other than a slightly longer procedure time and a slight increase in radiation time.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 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: 5895698
• MDR Text Key: 52727528
• Report Number: 3002808486-2016-00867
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529219
• UDI-Public: (01)10827002529219(17)170409(10)E3204067
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2014

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-65-2-UNI-CELECT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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