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 or Delayed Positioning (1157); Malposition of Device (2616)

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

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) k090140.Summary of investigational findings: the evaluation of the images indicate that one of the primary filter legs could be superimposed on one other primary filter leg.Furthermore, a tilt increases when a wire has been used to help open the filter.However, despite a significant tilt, the filter appears to have performed its function with a large amount of thrombus seen in the filter and below.The root cause for the filter did not open properly can not be determined, but the filter appearance is likely accounted for by the typical oval and fairly dynamic shape of the ivc.During the manufacturing qc processes the spring effect of filter is 100 % controlled, as they are all deployed after advancement through a sheath.Under normal conditions, ivc< 30 mm, the radial force of filter will make filter legs attach to ivc.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: the filter didn't open properly after deployment.It looks like the legs were stick together 2 by 2.The legs then started to open slowly and then completely with the help of wire movements to help open the filter.The filter did not migrate and had to be left in place because the patient is on antiplatelet therapy and has to get urgent surgery.They plan to change the filter in one week from now.Patient outcome: the patient will need a filter replacement.The doctor doesn't want to keep this tulip filter for more than one week.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: 6299224
• MDR Text Key: 66563734
• Report Number: 3002808486-2017-00209
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002213606
• UDI-Public: (01)10827002213606(17)170820(10)E3358828
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2015
• Date Device Manufactured: 08/20/2015
• 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