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

Catalog Number IGTCFS-65-1-JUG-CELECT-PT

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-1-jug-celect-pt.Investigation is still in progress.

Event Description

Description of event according to initial reporter: while trying to deploy, the physician hit all the required buttons and the filter would not deploy.Filter was resheated and the physician attempted to deploy.The filter was able to be deployed with no further complications.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.

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-1-jug-celect-pt.(b)(4).Summary of investigational findings: investigation is solely based on description of event.Since no device or imaging have been available, the exact root cause for what caused the alleged difficulty in deploying the filter is unknown.It is known from the literature that excessive back tension could result in deployment difficulties/failure when pressing the release button.The ifu addresses the issue through the statement "while keeping slight back tension on the introducer, push the release button completely to ensure proper release of the filter" and the warning "excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated".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 initial reporter: while trying to deploy, the physician hit all the required buttons and the filter would not deploy.Filter was resheated and the physician attempted to deploy.The filter was able to be deployed with no further complications.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN 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: 5982375
• MDR Text Key: 55790825
• Report Number: 3002808486-2016-01165
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)180319(10)E3313102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2016
• Date Device Manufactured: 03/19/2015
• 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