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

Catalog Number IGTCFS-65-2-UNI-CELECT-PT

Device Problems Difficult or Delayed Positioning (1157); Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog#: igtcfs-65-2-uni-celect-pt.Similar to device under 510(k) k121629.(b)(4).Summary of investigational findings: the introducer cannot be pushed all the way through the sheath.Due to a minor constriction in the tip of the sheat, the introducer could not be advanced and the filter not completely released.Based on these findings internal action has been taken and appropriate personnel have been notified.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to clinical study: two registrars were placing the filter in question under the watch of the physician as part of our clinical study.This was done from a right femoral approach, all went well right up to the placement.The filter was in a great position, as the filter was deployed the secondary legs deployed as they should but when it came to the primary legs it appeared that the radiopaque marker at the end of the deployment system was stopping this from happening.After a few attempts to deploy the feet and losing position a number of times the filter had to be deployed in the delivery system and the doctors used the dilator and another catheter to then push the filter out.The filter was deployed but due to the way this had to be done is now tilted, but is doing its job.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 Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 5895793
• MDR Text Key: 52732725
• Report Number: 3002808486-2016-00857
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)180608(10)E3336121
• 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: 07/27/2015

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-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• 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