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 09/24/2012

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: evaluation of this complaint is based solely on the description since no images or device have been available to assist the investigation.Therefore we are unable to determine exact reason for filter expanding difficulties.However, the filter may have been somehow obstructed from fully expanding, due to some biomechanical mechanisms e.G.A clot turning into fibrin formation or ivc anatomical conditions.Also the physician experienced difficulties when pressing the release button.Most likely this issue was caused due to possibility of clots/fibrin attachment while taking time before releasing the filter as.However the exact root cause for this issue is not to be determined based on the description and without investigation the device in question.No indications that this filter 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 user inserted the filter from the left jugular vein with no noted tortuous.The filter became released but the legs were not expanded fully.He could connect the filter to the filter introducer hook and continued the procedure.The filter legs expanded fully ultimately, but releasing was difficult.The filter became released after several pushes of the metal knob.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: 6295393
• MDR Text Key: 66319081
• Report Number: 3002808486-2017-00188
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)150111(10)E2858355
• 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: 09/26/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• 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: 09/26/2012
• Date Device Manufactured: 01/11/2012
• 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