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 or Delayed Positioning (1157); Kinked (1339)

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

Event Date 06/12/2014

Event Type  malfunction  

Event Description

Description of event according to initial reporter: a patient with dvt underwent ivc filter placement by left jugular approach on (b)(6) 2014.After the sheath system of the complaint device was advanced into the target site from left jugular vein, the physician attempted to insert the filter preloaded in the peel-away sheath into the sheath system.However, when advancing the filter into the sheath system through the peel-away sheath, feeling of strangeness was felt and therefore, it was retrieved and checked, which confirmed the deformation of the filter leg.Another device was used instead without problems.Patient outcome: no adverse effects to the patient.

Event Description

Description of event according to initial reporter: a patient with dvt underwent ivc filter placement by left jugular approach on (b)(6) 2014.After the sheath system of the complaint device was advanced into the target site from left jugular vein, the physician attempted to insert the filter preloaded in the peel-away sheath into the sheath system.However, when advancing the filter into the sheath system through the peel-away sheath, feeling of strangeness was felt and therefore, it was retrieved and checked, which confirmed the deformation of the filter leg.Another device was used instead without problems.Patient outcome: no adverse effects to the patient.

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-jp-jug-tulip.Similar to device under 510(k): k090140.Patient code:(b)(4) - no known impact or consequence to patient.Device code: (b)(4) - difficult to deploy 1339 - kinked.Summary of investigational findings: jugular introducer, peel-away sheath and filter returned.A minor kink found in the peel-away sheath may not have caused reported advancement difficulties.One of the secondary filter legs is slightly deformed and pushed upwards against the filter hook.Based on these findings it is suggested that the peel-away sheath with the collapsed filter was not properly placed in the sheath hub, when filter was advanced.This is supported by reported "feeling of strangeness" when filter was advanced through the peel-away sheath.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; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6299513
• MDR Text Key: 66519938
• Report Number: 3002808486-2017-00271
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)151128(10)E3014752
• 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: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• 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: 06/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2012
• 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