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 Positioning Failure (1158)

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

Event Date 11/06/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) (b)(4).(b)(4).Summary of investigational findings: the filter is undamaged and symmetric and distances between filter legs are 33.5mm, which is within the specifications (32-40mm).Attached imagings indicate that the tip of the sheath is uneven and that there are several marks in the tip of the sheath.The marks may have been caused by the anchors of the filter having been pulled back towards sheath tip.The blue sheath, the peek sheath and the introducer have been returned assembled, but the filter has been returned unloaded.The grasping hook can easily be advanced, but it has been straightened/pulled out of shape.The marks on the blue sheath caused by the anchors of the filter are so significant that it can be assumed that the filter was pulled back with such force that the grasping hook was straightened/pulled out of shape, too.The exact reason why the reported filter did not deploy cannot be determined.However, it is possible that filter did not release from introducer system, either because the blue button was not completely pushed, or maybe due to the fact that excessive back tension was applied to the system.It is known from the literature that excessive back tension could result in deployment difficulties/failure when pressing the release button.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: unable to deploy ivc filter.System removed and new system used.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 6272070
• MDR Text Key: 65569114
• Report Number: 3002808486-2017-00054
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529264
• UDI-Public: (01)10827002529264(17)170910(10)E3254466
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2014
• 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