MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G52916

Device Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: "the filter was deployed.There were issues disengaging the hook from the filter.The physician could not get the delivery system out, but images indicated the filter deployed.The images showed a separation of the filter from the delivery system.But, the physician was still having problems getting the delivery system out.Eventually, the physician was able to get the delivery system out.The filter was deployed and the patient is fine." patient outcome: no adverse effects on the patient due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Summary of investigational findings: investigation is based on event description and returned product.Based on information provided it is assumed that difficulties were encountered, when attempting to release the filter from the jugular introducer, not when attempting to advance the filter through the sheath.The jugular introducer, the blue sheath, and the long dilator were returned.An investigation of the introducer found the grasping hook moving freely and working as intended, when pressing the release button.The grasping hook itself was slightly straightened, but no more than what may occur, if the physician is "still having problems getting the delivery system out" and the device is manipulated during attempts to release the filter.However, 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".It is noted that the filter was deployed and the patient is fine.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.Cook medical will continue to monitor for similar events.

• Brand Name: GUNTHER TULIP 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
• MDR Report Key: 7211668
• MDR Text Key: 98287244
• Report Number: 3002808486-2018-00170
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)200830(10)E3625294
• Combination Product (y/n): N
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/10/2018
• Device Age: 4 MO
• Date Manufacturer Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1