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

Catalog Number IGTCFS-65-JP-JUG-TULIP

Device Problems Difficult or Delayed Positioning (1157); Activation Failure (3270)

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

Event Date 04/03/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-jp-jug-tulip.Pma 510(k): similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: filter returned withdrawn in the introducer sheath with a gtrs loop.Filter and loop could be advanced through the sheath.No damages to any component, which could have indicated them being exposed to manipulation beyond their intended design.Despite several reported unsuccessful attempts to deploy the filter, the filter is nice and symmetric and with correct distances between primary filter legs.The exact reason for non expanding filter legs cannot be determined, but they may have been somehow obstructed from fully expanding due to e.G.Ivc anatomical conditions, clots or if not placed in ivc.Same conditions/clots may have prevented filter collapse when physician attempted to resheath the filter.In all filters the spring effect and the distances between filter legs are verified during the manufacturing processes, as every filter is redeployed and spring effect is approved after advancement through a testing sheath.Under normal conditions, ivc< 30 mm, the radial force of the filter will secure proper attachment of the filter legs to ivc.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: an obese man experienced ivc filter placement.The vessel diameter of the patient was small.The physician advanced the filter introducer below renal vein by right jugular approach through the sheath system.However, the legs of the filter did not expand, though it was advanced out of the sheath.Only the middle part of the filter expanded a little.Therefore, he attempted to get the filter back into the sheath by pushing the sheath forward, but it was unsuccessful.He felt like the filter got stuck in/on the sheath somehow.Thus, he attempted to let the filter back into the sheath by withdrawing the filter introducer back next, which ended up in the vein.So, he stopped the attempts to get the filter back into the sheath and determined to deploy the complaint filter once above renal vein and retrieve the deployed filter by snare afterward.However, the legs did not expand and filter could not be deployed this time either.Therefore, he retried the attempts to get the filter back into the sheath, but it failed, in addition, the filter disconnected from the grasping hook and got stuck in the tip of the sheath then.A wire guide was inserted into the sheath and the whole system was retrieved at the same time with the filter.Another gunther was placed instead without problems.Patient outcome: no adverse effects to the patient.

• Brand Name: GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6299215
• MDR Text Key: 66433770
• Report Number: 3002808486-2017-00198
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)161119(10)E3156664
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-JP-JUG-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2013
• 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
• Patient Outcome(s): Required Intervention