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 Problem Difficult or Delayed Positioning (1157)

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

Event Date 04/08/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-jp-jug-tulip.Similar to device under 510(k): k090140.Summary of investigational findings: investigation showed that grasping hook functioned as intended.No indications that this device was not manufactured according to specifications.Based on these information it is not possible to find the exact root cause why the filter would not release, but excessive tension may have resulted in deployment difficulties/failure when pressing the release button.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: the device was used for ivc filter placement by right jugular vein approach.The physician pushed the metal knob to release the filter.However, it could not be released.When he pushed the knob some times, it could be released at last.Patient outcome: no information provided.

• 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: 6272076
• MDR Text Key: 65569644
• Report Number: 3002808486-2017-00037
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)151219(10)E3024967
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/10/2013
• Initial Date FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2012
• 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