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

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

Event Date 06/06/2012

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: evaluation is based on the description solely, since no images or product were provided.It is stated that patient had a tortuous anatomy.Most likely the difficulty encounted was due to the tortuous anatomy and to the thrombus.Excessive force had to be applied and consequently, the filter detached inside the sheath.The cause of the event could be e.G.The grasping hook was straightened while excessive force was applied to retract the filter, or the release button was inadvertently pushed during the manipulation.No evidence to suggest 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: on (b)(6) 2012, ivc filter placement was performed.The delivery system was inserted from right internal jugular vein and the sheath was withdrawn to expand the filter.However, the filter was retracted into the sheath a couple of times since the filter was tilted due to tortuosity of ivc.When the same attempt was made a couple of times and the filter was in the sheath, resistance was encountered.Strong force was applied to manipulate the filter and consequently the filter became detached.Whole delivery system with the filter was removed and another manufacturer's filter was placed.Patient outcome: no adverse effect on the patient.

• 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: 6292156
• MDR Text Key: 66216501
• Report Number: 3002808486-2017-00163
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)150124(10)E2865006
• 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: 06/11/2012

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?: No
• Is this a Product Problem Report?: Yes
• 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: 06/11/2012
• Date Device Manufactured: 01/24/2012
• 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