MAUDE Adverse Event Report: WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FEMORAL APPROACH; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-JP-FEM-TULIP

Device Problems Difficult or Delayed Positioning (1157); Retraction Problem (1536)

Patient Problem No Code Available (3191)

Event Date 12/24/2014

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-jp-fem-tulip.Similar to device under 510(k) k090140.Summary of investigational findings: investigation evaluation confirms that the physician could not release the filter from the femoral introducer and it was confirmed that 80% of the filter was re-sheathed.However, the degree af re-sheathing offers no insight on why the filter legs did not release/deploy from filter introducer.Investigation of returned device showed no difficulties during simulated deployment test on the table.Filter expanded after release and no evidence was found to suggest that device was not manufactured according to specifications.The exact root cause for the difficulties experienced remains unknown.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: on (b)(6) 2014: a female with pulmonary thromboembolism underwent ivc filter placement by right femoral approach.The sheath system and the filter introducer of the complaint product were advanced from right femoral vein and deployment of the filter was attempted.However, although the physician pulled the red hub backward enough to contact the pinvise, the legs of the filter would not expand and the filter could not be released.Therefore, he tried to retract the filter back into the sheath, but the secondary legs got deformed (pulled up to the filter hook) during that attempt and due to the deformation, when only 4/5 of the filter was pulled back into the sheath, the filter got stuck at the tip of the sheath and became impossible to withdraw back further.The physician pulled back the sheath to the common femoral vein under that condition (filter was stuck at the tip and 1/5 of the filter was still extending out of sheath) and tried to retrieve it out of the body, but as the patient complained pain, retrieval was given up.The sheath system and the filter introducer still with filter were remained in the body as they were determined to be retrieved by surgical operation the next day.On (b)(6) 2014: the sheath system and the filter introducer were retrieved successfully by surgical operation as planned.Although blood transfusion was conducted as the amount of bleeding after the operation was large, there seemed to be no threat to the patient's life.Patient outcome: on (b)(6) 2014: although monitoring is necessary, there seems to be no threat to the patient's life.

• Brand Name: GÜNTHER TULIP VENA CAVA FEMORAL 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: 6272085
• MDR Text Key: 65565581
• Report Number: 3002808486-2017-00034
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037755
• UDI-Public: (01)00827002037755(17)170502(10)E3210849
• 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: 12/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-JP-FEM-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2014
• 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