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 Kinked (1339); Failure to Advance (2524)

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

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: introducer and two sheaths returned.Components for this and (b)(4) are returned in the same pouch.It is unknown which of the two sheaths the introducer belongs to.The penetration of the sheath for this complaint and the kink in the sheath for (b)(4) are located at exactly the same place around 38cm from the fitting.Although it apparently was possible to deploy a filter properly at a third attempt, it is certainly a difficult approach that caused the incident.Under normal conditions the introducer sheath is strong enough to accomplish the procedure, but it may kink if excessive force is used to advance it, and the filter may be prone to exceed the sheath wall if advanced through a kinked sheath.The two incidents are therefore very comparable, which indicate the cause is related to procedural circumstances.However, without further information the specific cause cannot be identified.It is noted that the event did not harm the patient and that the procedure was completed successfully using a third device.To address the issue, the ifu states that in cases where some problem has occurred such as resistance when the filter delivery catheter is advanced into the sheath, the operation should be suspended and the cause ascertained and, if necessary, the entire system should be pulled out together with the sheath.There is no evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook medical will continue to monitor for similar event.

Event Description

Description of event according to initial reporter: access was gained from right internal jugular vein and no tortuous anatomy was observed from right internal jugular vein to ivc.The patient's anatomical form was suitable for the procedure.First, the sheath was advanced into ivc over the wire guide after dilated puncture site with dilator, then the filter introducer was inserted into the sheath.However, filter introducer got stuck inside of the sheath around ivc area.The physician attempted to advance the filter introducer with force, therefore the filter leg(s) perforated the sheath.So, the whole system was removed from the patient's body.Then, another lot # of the same device was used, and the sheath was inserted same manner as the first device.However, the filter introducer got stuck at the same area and it was confirmed that the sheath got kinked.The whole system was removed from the patient's body again and another lot # of the same rpn was used instead to complete the procedure.Patient outcome: there have been no adverse effects to the patient reported.

• 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: 6275490
• MDR Text Key: 65666040
• Report Number: 3002808486-2017-00100
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)180909(10)E3364639
• 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: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• 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: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2015
• 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