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 Device Handling Problem (3265); Activation Failure (3270)

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

Event Date 05/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(4).Catalog# igtcfs-65-jp-jug-tulip.(b)(6).Similar to device under 510 (k): k090140.(b)(4).Investigation is still in progress.

Event Description

Description according to initial reporter: the male patient was suitable for the procedure since his anatomy was normal without any problem.Approach was gained from the right jugular vein.When the physician attempted to deploy the filter in the ivc below the renal veins, filter legs did not expand.Therefore, the filter was repositioned inside the sheath.Then the sheath with the filter was removed from the patient.(after the removal, the filter was detached from the introducer.) the physician decided to postpone the procedure.Patient outcome: there have been no adverse effects to the patient reported.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Manufacturers ref# (b)(4).Summary of investigational findings: the complete classic, tulip set was returned and an investigation of the filter found one secondary leg (blade) pushed upwards against the clip bushing.The filter is symmetrical, but the distance between the primary filter legs is slightly decreased.The sheath is severely damaged with several kinks and squeezed lumen on the shaft and with grooves and burrs in the tip.The groves and the burrs may have been caused by the filter anchors, when the filter "was repositioned inside the sheath".The grasping hook was straightened, probably as a consequence of the filter anchors sticking on the sheath tip, when attempting to withdraw the filter into the sheath for repositioning.The exact reason why the filter would not expand cannot be determined, but based on the investigation findings it is suggested that the components were exposed to manipulation beyond their intended design during the procedure and that said manipulation also affected the distance of the filter legs.However, it is seen before that the filter legs can be somehow obstructed from fully expanding due to e.G.Ivc anatomical conditions, clots or if the filter is not placed in ivc.It is noted that patient did not experience any adverse effects.There is no evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

• Brand Name: GÜNTHER 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
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 6621325
• MDR Text Key: 76974946
• Report Number: 3002808486-2017-01231
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)191017(10)E3507833
• 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,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• 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
• Distributor Facility Aware Date: 05/18/2017
• Device Age: 7 MO
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2016
• 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