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 Bent (1059); Difficult or Delayed Positioning (1157)

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

Event Date 03/07/2012

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: introducer system, dilators, and sheath returned in the tray.Found introducer system nice and straight except from a minor bend in the middle.Locking mechanism was unlocked.Introducer and grasping hook manufactured according to specifications and working as intended.The damaged filter leg may be due to reported rotation, and the filter not expanding in the first place may be due to a clot turning into fibrin formation or due to other biochemical mechanism during the procedure.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: ivc filter placement was performed.When the physician withdrew the sheath, the filter was not expanded.The filter was retracted into the sheath and the delivery catheter was rotated once.Then the sheath was withdrawn again and the filter was expanded adequately.The position was confirmed and the filter was released.At that point, it was observed the secondary leg was damaged and turned outward.The physician attempted to remove the filter with a gooseneck snare, however it was not retracted due to the tuned filter although the filter hook was caught with the snare.The procedure was completed because there did not seem to be any better way to treat this.Patient outcome: the patient is fine.

• 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: 6292213
• MDR Text Key: 66225361
• Report Number: 3002808486-2017-00208
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)141111(10)E2827058
• 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: 03/09/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• 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: 03/09/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2011
• 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