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 Problem Difficult to Advance (2920)

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

Event Date 10/30/2013

Event Type  No Answer Provided  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# igtcfs-65-jp-fem-tulip.Similar to device under 510(k)k090140.(b)(4).Summary of investigational findings: the sheath with femoral introducer and attached filter returned.Sheath severely accordioned in three areas.A single notch found in sheath tip.Sheath was cut open at distal end and revealed the femoral loaded filter placed with hook approx.2cm from tip and with secondary legs bending upwards and pass the filter hook.Since reported "1-2cm of the distal filter was expanded" attempts may have been made to withdraw the expanded secondary legs into the sheath to verify and "stabilize the position" and the withdrawn/damaged "filter stuck inside the sheath and the sheath would not be moved".The filter may have accordioned during attempts to deploy the sticking/damaged filter.No evidence exist to suggest that product is not manufactured according to specifications.Cook medical will continue to monitor for similar events.Manufacturer ref# (b)(4).Catalog# igtcfs-65-jp-fem-tulip.Similar to device under 510(k)k090140.(b)(4).Summary of investigational findings: the sheath with femoral introducer and attached filter returned.Sheath severely accordioned in three areas.A single notch found in sheath tip.Sheath was cut open at distal end and revealed the femoral loaded filter placed with hook approx.2cm from tip and with secondary legs bending upwards and pass the filter hook.Since reported "1-2cm of the distal filter was expanded" attempts may have been made to withdraw the expanded secondary legs into the sheath to verify and "stabilize the position" and the withdrawn/damaged "filter stuck inside the sheath and the sheath would not be moved".The filter may have accordioned during attempts to deploy the sticking/damaged filter.No evidence exist to suggest that product is not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: the sheath system was advanced via the right femoral vein and placed below the renal veins.When the filter introducer was advanced through the sheath, it noted that 1-2cm of the distal filter was expanded.After correct position has been verified, the physician stabilized the position of the filter introducer and attempted to withdraw the 8.5f sheath.However, strong resistance was felt due to the filter stuck inside the sheath and the sheath would not be moved.The partially expanded filter was successfully pulled back into the sheath and the whole system was removed.After hemostasis of the right femoral vein, the left femoral vein was punctured and filter placement was performed using another device without problems.Patient outcome: no adverse effect to the patient.

• 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: 6265760
• MDR Text Key: 65359716
• Report Number: 3002808486-2017-00048
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037755
• UDI-Public: (01)00827002037755(17)160718(10)E3112686
• 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: 11/01/2013

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?: 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: 11/01/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2013
• 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