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

Catalog Number IGTCFS-65-JP-JUG-TULIP

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Pma/510k: similar to device under pma/510(k) k172557.Investigation is still in progress.

Event Description

Description of event according to initial reporter: ivc filter placement was performed.Approach was gained from the right jugular vein.The user advanced igtcfs-65-jp-jug-tulip, lot.E3796211 to the desired position and he pushed the release button but the filter was not released.He pushed the button several times but the filter was not released.A device from another manufacturer was used instead and the procedure was completed.Patient outcome: there have been no adverse effects to the patient reported.

Manufacturer Narrative

Manufacturers ref#: (b)(4).Summary of investigational findings: the user advanced igtcfs-65-jp-jug-tulip to the desired position and he pushed the release button, but the filter was not released.He pushed the button several times, but the filter was not released.Another device was used instead, and the procedure was completed.There has been no adverse effects to the patient.Introducer dilator, sheath and tulip filter were provided for product evaluation.Blood/biological matter was present.The sheath had kinks, a mark was noticed, and it looks like a scratch from the inside of the sheath.The tip of the sheath had some dents.Per the product evaluation, it is unknown what may have caused the reported adverse event.Review of device history record showed no evidence to suggest that the device was not manufactured according to specification.According to instruction for use excessive force should not be used to place the filter.Based on the information and product evaluation it has not been possible to establish the likely cause of event, but excessive back tension could result in difficulty for the release mechanism which caused the filter not to be 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.

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 VENA CAVA FILTER JUGULAR APPROACH
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9068932
• MDR Text Key: 158643105
• Report Number: 3002808486-2019-01481
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)211113(10)E3796211
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2021
• Device Catalogue Number: IGTCFS-65-JP-JUG-TULIP
• Device Lot Number: E3796211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1