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

Catalog Number IGTCFS-65-1-JUG-TULIP

Device Problems Difficult to Remove (1528); Activation Problem (4042)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Occupation: non-healthcare professional.Pma/510(k) k172557.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: we received information on 02dec2019 that shows that there were two devices involved in the implant and one had to be removed.The ivc was patent with normal configuration and caliber and was free of thrombus.The initial inferior vena cava filter failed to deploy properly and had to be recovered.This recovery was complicated by laceration to the inferior cava which was treated by balloon tip not.The level of the renal veins was noted.The inferior vena cava filter was deployed in the infrarenal inferior vena cava.Patient outcome: follow up intervening cavogram demonstrated no active extravasation of contrast.A new inferior vena cava filter was deployed.

Manufacturer Narrative

Manufacturers ref# pr286525.Summary of investigational findings: it was reported that the filter failed to deploy properly and had to be recovered, but recovery was complicated by laceration to ivc, which was treated by balloon tip not.No product was returned for investigation and without the actual complaint device it may be inappropriate to speculate at what may or may not have caused the difficulties encountered, when attempting to release the filter.However, the instructions for use specify to press the release button completely to ensure proper release of the filter and also, that excessive back tension applied to the system during attempted filter release may prevent the filter from releasing when the release mechanism is activated.No evidence to suggest product was not manufactured according to specifications cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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.

Event Description

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

• 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: 9443363
• MDR Text Key: 178333525
• Report Number: 3002808486-2019-01949
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• 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-TULIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 63