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 01/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: the investigation of the returned parts relates to both (b)(4).The components are returned in one package with no individual marking.Therefore, it cannot be identified which components relates to (b)(4).Two jugular introducer, two filters and several dilators are returned.Sheath 1: there is two kinks.The kinks are located approximately 20 cm and 30 cm from the distal end.No penetration on the kink located 20 cm from the distal end.On the other kink there is a penetration on the backside of the kink.Sheath 2: there is six severe kink.The six severe kinks are located approximately on the same location as on sheath 1.There are nothing else to notice on the returned.It is most likely the strong resistance experienced that is the root cause for the kinks.Under normal conditions the sheath is strong enough to accomplish the procedure, but the introducer sheath may kink if excessive force is used to advance it through tortuous anatomy.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: approach was gained from jugular vein, and the puncture site was dilated with the dilator first.While advancement of the sheath system, the physician met strong resistance, however, the sheath would advance to the desired lesion.Then, the filter introducer was advanced through the sheath, but it would not advance.The sheath and the filter introducer were removed form the patient, and the physician noticed that the sheath got kinked.Since he pushed the filter introducer with force into the sheath, some part of the sheath had a hole.((b)(4), lot e3392103) another lot of the same device was used instead, however the same event occurred.((b)(4), lot e3380305) therefore, the access site was changed to fem and igtcfs-65-jp-fem-tulip was used, and complete the procedure successfully.Additional information received 26jan2016: the physician who performed procedure punctured external jugular vein by mistake.Therefore, this complaint occurred by physician's 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: 6299543
• MDR Text Key: 66433604
• Report Number: 3002808486-2017-00275
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)181027(10)E3380305
• 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: 01/20/2016

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?: No
• 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: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• 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
• Patient Outcome(s): Required Intervention