MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-UNI

Device Problems Difficult To Position (1467); Malposition of Device (2616)

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

Event Date 08/18/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) (b)(4).(b)(4).Summary of investigational findings: long dilator, blue sheath, jugular introducer, and femoral introducer with loaded filter returned.Secondary filter legs/wires are deformed and pulled upwards against filter hook.Also, marks were noted on the tip of the introducer sheath.Both observations confirming, that attempts had been made to reposition the pre-exposed filter as reported.The exact reason for the straightened filter hook cannot be determined, but after retrieval, attempts may have been made to pull the filter from the piston/cup without advancing the introducer.Ifu, warning: the slightly expanded filter can be repositioned proximally or distally, but not pulled back into the sheath; doing so will most likely damage the filter.No evidence to suggest that device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

While trying to deploy the ivc filter through femoral approach, we were not able to reposition the filter and the hook of the filter was found caught in the venous wall and it stained the vessel.Later it was found that the hook was not in j shape.

• Brand Name: GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET
• 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: 6272091
• MDR Text Key: 65571430
• Report Number: 3002808486-2017-00053
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2014

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-UNI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2014
• 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 Age: 49