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 08/24/2016

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: the entire product is returned.Investigation of the returned product found a heavy penetration 42 cm.From the distal end.From the penetration site to the distal end, there are many small kink tendencies.The grasping hook is pulled out of shape, which probably occurred during the withdrawal of the filter after penetration.The filter is fine and symmetrical and does not look like it has been through a penetration.The leg width is according to specifications and all primary leg ends looks fine.Due to the many kinks, the root cause for the reported event is determined to be a difficult approach in the patient (e.G.Tortuous anatomy).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.The ifu states that excessive force should not be used to place the filter.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar event.

Event Description

Description of event according to initial reporter: access was gained from right jugular vein to perform ivc filter placement.There was vessel bend at near the puncture site of jugular vein.The sheath was inserted first, then the filter introducer was advanced into the sheath, however the filter leg(s) perforated to the sheath.Therefore, another device was used by inserting the sheath again to complete the procedure.Patient outcome: no adverse effect to the patient due to this occurrence.

• 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: 6275495
• MDR Text Key: 65667027
• Report Number: 3002808486-2017-00107
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)190630(10)E3467673
• 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: 08/25/2016

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: 08/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• 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