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 Positioning Failure (1158); Material Deformation (2976)

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

Event Date 04/25/2012

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: one image is received for investigation.The filter was returned.All filter legs are more or less deformed.It is not possible to draw any conclusion on why the filter is deformed.Based on the limited information, it is not possible to determine exact reason for filter expanding difficulties.However, the filter may have been somehow obstructed from fully expanding, either due to a clot turning into fibrin formation or due to other biochemical mechanism during the procedure.Also, if the filter is deployed in a small/flat vena cava, the filter would not fully expand until the vena cava is in a normal shape.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: during the procedure, the filter cannot deployed as the steel wire of the filter was twist together.Doctor retrieved the filter, change another product to finish the procedure.Patient outcome: the patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

• 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: 6295391
• MDR Text Key: 66319117
• Report Number: 3002808486-2017-00173
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002213606
• UDI-Public: (01)10827002213606(17)140207(10)E2871751
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• 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: 06/19/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2012
• 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