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 09/09/2013

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: visual inspection of the returned device showed that the jugular introducer and the introducer sheath was returned.A kink was observed in the transition of the handle and shaft in the handle end of the introducer and another kink was observed right below the hub in the proximal end of the introducer.Further investigation confirmed that the cannula with the grasping hook was fractured in handle and also fractured in the transition between handle and shaft located in the kinked area on the introducer.The grasping hook was noted to be deformed in shape.According to the description, it was possible to release the filter.However, difficult to withdraw the sheath which might be due to the kinked cannula and sheath, as suggested by the rep.However it is unknown how and when this kink occured why the exact root cause remains unknown.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: the device was introduced via the right jugular vein.The physician attempted to release the filter but the sheath would not be withdrawn properly so the filter hook was still covered.Since the filter was placed in the correct position and legs gripped on the vessel wall, it was released by pushing the metal button.After removal of the delivery system, the sheath was able to be withdrawn but the grasping hook was not present at the tip of the catheter.Additional information received 09oct2013: the grasping hook was not identified under fluoroscopic guidance.Patient outcome: the patient did not experience any adverse effects 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: 6266058
• MDR Text Key: 65360811
• Report Number: 3002808486-2017-00008
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)160212(10)E3045549
• 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: 09/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• 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: 10/09/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2013
• 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