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 Filtration Problem (2941)

Patient Problem No Code Available (3191)

Event Date 02/13/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: no imaging was provided and no product was returned.Based on the limited information provided, it would be inappropriate to speculate at what may or may not have occurred leading to the reported lung infarction.However, it is unknown if the filter was tilted and or if the filter contributed to cause pulmonal embolism and if the pe caused the lung infarction.No indication that this filter was not manufactured according to specifications and the exact root cause remains unknown based on the available information.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: on (b)(6) 2013, a filter was placed for prevention of lung infarction.There was no problem about the procedure.On (b)(6) 2013, the patient developed lung infarction and went into shock.Thrombolysis was performed and the patient recovered.Patient outcome: the patient recovered after thrombolysis.

• 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: 6292147
• MDR Text Key: 66215187
• Report Number: 3002808486-2017-00158
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)150607(10)E2928980
• 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: 02/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 02/21/2013
• Date Device Manufactured: 06/07/2012
• 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
• Patient Outcome(s): Life Threatening; Required Intervention