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 Thrombus (2101)

Event Date 03/04/2014

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog#: igtcfs-65-jp-jug-tulip.Similar to device under 510(k): k090140.(b)(4).Summary of investigational findings: based on the limited information provided, it is unknown if the filter performance was related to this occurrence and consequently the exact root cause for the reported pe recurred after ivc filter placement cannot be determined.No report of filter tilt/misplacement.No indication that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: the complaint device was placed in the ivc on (b)(6) 2014, which was planned to be retrieved on (b)(6) 2014.After the filter placement, anticoagulation therapy had been performed, but on (b)(6) 2014, pe recurred though the filter was still in the ivc.As a result of the exam of the patient, it was suspected that the patient had the history of hit.Large amounts of the blood clots were observed not only in the pulmones, but also in the filter.The physician plans to begin thrombus resolution on (b)(6) 2014.Additional information received 19mar2014: as the possibility that the patient had hit was suspected, thrombus resolution was started on (b)(6) 2014.The physician determined to monitor the patient for a while.Likelihood that the filter retrieval will be performed in the future is low at the moment.Patient outcome: thrombus resolution was started on (b)(6) 2014.

• 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: 6275509
• MDR Text Key: 65671160
• Report Number: 3002808486-2017-00071
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)160227(10)E3051755
• 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,u
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 01/25/2017
• Date Device Manufactured: 02/27/2013
• 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
• Patient Outcome(s): Life Threatening