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 Type  malfunction  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: "during deployment of filter from the jugular approach, the filter would not deploy from the delivery system.Physician pressed the button multiple times, tried manipulating the system, but was not able to get the filter to release from the system.The physician was able to resheath the filter and remove it from the patient.A second filter was opened and deployed without incident".Patient outcome: there was no harm to the patient.

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-1-jug-celect-pt.(b)(4).Summary of investigational findings: no imaging was provided and no product was returned.Therefore, it would be inappropriate to speculate at what may or may not have occurred based on the limited information made available to us.It is noted, that the device was removed from the patient and a new device was used to complete the procedure.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: "during deployment of filter from the jugular approach, the filter would not deploy from the delivery system.Physician pressed the button multiple times, tried manipulating the system, but was not able to get the filter to release from the system.The physician was able to resheath the filter and remove it from the patient.A second filter was opened and deployed without incident".Patient outcome: there was no harm to the patient.

• 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: 6224393
• MDR Text Key: 63917214
• Report Number: 3002808486-2017-00003
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)190929(10)E3500849
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• 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?: No
• Date Manufacturer Received: 12/30/2016
• Date Device Manufactured: 09/29/2016
• 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