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); Malposition of Device (2616); Device Handling Problem (3265)

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

Event Date 12/25/2013

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-jp-jug-tulip.Pma 510(k): similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: most likely the filter jumped as pushed out of the sheath and placed tilted in the right common iliac artery, due to the technical error of pushing release button before the filter was free of the sheath.The difficult retrieval was most likely due to filter tilt and filter hook adherence to the inside of the ivc, a clinical situation known from the literature.No evidence to suggest that 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: on (b)(6) 2013: ivc filter placement was performed.The patient's anatomical form was suitable for the procedure.The delivery system was advanced from the right internal jugular vein.Then the physician accidentally release the filter before it was completely free of the sheath.As he pushed the filter with the filter introducer, it was jumped out of the sheath and placed in the right common iliac artery.The filter legs were positioned 2 mm from the origin of the right common iliac artery with the hook tilted to the left.The physician attempted to retrieve the filter using a 6 fr.Sheath (destination, terumo) and gooseneck snare but it failed as the filter hook had adhered to vessel.On (b)(6) 2013: filter retrieval was attempted using a gunther tulip filter retrieval set but it also failed as the filter hook had adhered to vessel.Patient outcome: no adverse effect to the patient.

• 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: 6278357
• MDR Text Key: 65764614
• Report Number: 3002808486-2017-00113
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)160402(10)E3067207
• 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: 12/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2013
• Date Device Manufactured: 04/02/2013
• 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