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 to Remove (1528); Material Perforation (2205); Deformation Due to Compressive Stress (2889); Appropriate Term/Code Not Available (3191)

Patient Problem Perforation of Vessels (2135)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-jp-jug-tulip.Name and address for importer site: (b)(4).Similar to device under 510(k): k090140.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: ivc filter placement was performed.There was a tortuousity in the area between the punctured site(left jugular vein) and the ivc.The sheath system of the complaint igtcfs-65-jp-jug-tulip was advanced to the ivc using a wire guide (radifocus 35 / terumo) and a component dilator.Dilator and the wire guide were retrieved and then, the advancement of the filter introducer to the target site through the sheath was begun.During the delivery, slight resistance was encountered, but the physician continued pushing the introducer.When the resistance occurred, not the filter but the ivc was monitored through the fluoroscope.Since the introducer became impossible to push forward/pull back after the pushing, the physician shifted the monitoring area of fluoroscope to the vessel around the left jugular vein, confirming that the filter had perforated the sheath wall and penetrated the brachiocephalic vein.The physician pushed forward/pulled back the filter introducer with force, but the filter could not be retrieved.It detached from the grasping hook and was released then.Although gtrs was used in order to retrieve the released filter, the retrieval resulted in failure.Therefore, the left brachiocephalic vein was cut opened and the filter was retrieved out of the body surgically.Ivc filter placement was canceled.Patient outcome: although the patient¿s life was not threatened by this event, the hospitalization period was prolonged.Pe of the patient was not worsened due to the impossibility to place the filter.

Event Description

Description of event according to initial reporter: ivc filter placement was performed.There was a tortuousity in the area between the punctured site(left jugular vein) and the ivc.The sheath system of the complaint (b)(4) was advanced to the ivc using a wire guide (radifocus 35 / terumo) and a component dilator.Dilator and the wire guide were retrieved and then, the advancement of the filter introducer to the target site through the sheath was begun.During the delivery, slight resistance was encountered, but the physician continued pushing the introducer.When the resistance occurred, not the filter but the ivc was monitored through the fluoroscope.Since the introducer became impossible to push forward/pull back after the pushing, the physician shifted the monitoring area of fluoroscope to the vessel around the left jugular vein, confirming that the filter had perforated the sheath wall and penetrated the brachiocephalic vein.The physician pushed forward/pulled back the filter introducer with force, but the filter could not be retrieved.It detached from the grasping hook and was released then.Although gtrs was used in order to retrieve the released filter, the retrieval resulted in failure.Therefore, the left brachiocephalic vein was cut opened and the filter was retrieved out of the body surgically.Ivc filter placement was canceled.Patient outcome: although the patient¿s life was not threatened by this event, the hospitalization period was prolonged.Pe of the patient was not worsened due to the impossibility to place the filter.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description, returned device, and imaging provided.The introducer, the sheath, the long, and the short dilator were returned, but no filter.On the sheath a severe penetration was noted approx.31.5cm from the tip.On the introducer the grasping hook was slightly straightened.An image review revealed the patient's anatomy was such that the junction between the left internal jugular vein and innominate vein resulted in a near 90° angle.The angle at the confluence of the left internal jugular vein and innominate vein facilitated the kinking of the deployment sheath and with continued forward pressure on the ivc filter, the filter perforated the side of the ivc filter deployment sheath, resulting in the filter extending through the sidewall of the sheath.Instead of stopping when resistance was encountered, the deploying physician continued to push forward/pull back the filter introducer with force, resulting in the filter perforating through the wall of the deployment sheath and the filter feet appearing to extend into the left subclavian and innominate vein.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 through tortuous anatomy and the filter may be prone to exceed the sheath wall if advanced through a kinked sheath.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.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.

• 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
• MDR Report Key: 7551843
• MDR Text Key: 109482140
• Report Number: 3002808486-2018-00603
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)191221(10)E3533958
• 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: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2019
• Device Catalogue Number: IGTCFS-65-JP-JUG-TULIP
• Device Lot Number: E3533958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Distributor Facility Aware Date: 05/08/2018
• Device Age: 16 MO
• Date Manufacturer Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention