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 Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-1-uni-celect-pt (b)(4).Summary of investigational findings: no product or images have been received for investigation, such that the evaluation is based on the description solely.Based on the information provided, the exact reason for the deployment difficulties cannot be determined, however it is known from the literature that excessive back tension could result in deployment difficulties/failure when pressing the release button.From the ifu: - 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.- excessive tension during deployment may prevent the filter from releasing when release mechanism is activated.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: the filter would not deploy.After several attempts from the jugular approach, the filter would not unhook from the system.The physician re sheathed the filter a few times and then was finally able to detach it from the deployment system.Everything ended up being ok.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: 5899579
• MDR Text Key: 52847984
• Report Number: 3002808486-2016-00947
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)170903(10)E3251812
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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
• Type of Report: Initial
• Report Date: 09/19/2014

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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2014
• Date Device Manufactured: 09/03/2014
• 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
• Patient Outcome(s): Other