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

Catalog Number IGTCFS-65-2-UNI-TULIP

Device Problem Occlusion Within Device (1423)

Patient Problem Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Similar to device under 510(k): k090140.(b)(4).Summary of investigational findings: according to the description of event, a clot was "trapped in the filter causing issues with patient mobility and very swollen legs." no image is provided to assist the investigation and patient's medical records are unknown at this time.Therefore, it would be inappropriate to speculate on what may or may not have led to the reported clot in the filter causing issues with patient mobility.Reference is made to ifu, potential adverse events: pulmonary embolism, filter embolization, vena cava occlusion or thrombosis.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: clot trapped in the filter causing issues with patient mobility and very swollen legs.Patient put on warfarin.Patient outcome: unknown as information was not provided.

• Brand Name: GUNTHER TULIP NAVALIGN 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: 6335130
• MDR Text Key: 67538795
• Report Number: 3002808486-2017-00369
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-TULIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2014
• Initial Date FDA Received: 02/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention