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

Model Number G34309

Device Problems Difficult or Delayed Activation (2577); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).510(k): k171712.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: a patient underwent a jugular ivc filter placement procedure.After cavagram and following normal protocol prior to jugular ivc filter placement, the physician presses red then blue button to deploy g34309 lot #e3858939.Filter would not deploy despite pressing blue button numerous times.After twisting the introducer and catheter system, filter finally deployed but at 12 degree tilt.No further procedures needed.Patient is fine.Will bring back patient as soon as possible (or in better health) to reposition filter.Patient outcome: the patient did require an additional procedures due to this occurrence: will bring back patient as soon as possible (or in better health) to reposition filter.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: a patient underwent a jugular ivc filter placement procedure.The physician tried to deploy but was unable to despite pressing the release button numerous of times.After twisting the introducer and catheter system, the filter finally deployed but at 12-degree tilt.The patient is fine, but the filter will be repositioned as soon as possible.Review of device history record showed no evidence to suggest that the device was not manufactured according to specification.According to the instruction for use excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.Based on the provided information a likely cause is that tension prevented the filter from being released.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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
• MDR Report Key: 8934216
• MDR Text Key: 158617404
• Report Number: 3002808486-2019-01308
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)220529(10)E3858939
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2022
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3858939
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention