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

Model Number G34309

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# igtcfs-65-1-jug-celect-pt.(b)(4).Investigation is still in progress:.

Event Description

Description of event according to initial reporter: "filter would not release off of jugular deployment system, red button was stuck and filter had to be pushed out of delivery and then recaptured and retrieval via snare catheter.A new device was used and placed without issue." additional information provided 06 mar 2018: "upon delivery and insertion into the blue sheath the red button on the filter delivery handle was stuck in the depressed mode and filter would not release.The delivery system was then removed out of the blue sheath and a new filter delivery was placed through the existing sheath.After new filter was placed with no incident the physician inspected the malfunctioning device on the back table and was able to push the filter out but the button both red and blue seemed to be working improperly." patient outcome: "there was no patient harm no adverse event no additional procedure required to the patient.".

Manufacturer Narrative

Exemption number e2016032.(b)(4).Summary of investigational findings: only the jugular introducer was returned.The red locking mechanism was pressed, ie the system was unlocked.The filter was not returned, but investigation found the red locking mechanism as well as the blue release mechanism working as intended and therefore, the exact reason for the difficulties encountered, when attempting to release the filter cannot be determined.However, according to ifu excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.Cook medical will continue to monitor for similar events.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 7326363
• MDR Text Key: 102100761
• Report Number: 3002808486-2018-00342
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)201011(10)E3640547
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/26/2018
• Device Age: 4 MO
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 05/14/2018
• Supplement Dates FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2017
• 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