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 Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2012

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: one kink 24 cm from the hub probably caused the difficulties encountered when attempting to advance the filter.Excessive force caused the filter to perforate the sheath.All the struggle most likely caused the premature deployment of the filter inside the sheath.Under normal conditions the sheath is strong enough to accomplish the procedure, but it has been seen before that the sheath may kink if somehow exposed to excessive force because of tortuous anatomy.And if filter is advanced through a kinked sheath, the filter legs may be prone to exceed the sheath wall.No evidence to suggest that the 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 physician inserted a igtcfs-65-jp-jug-tulip from the jugular vein and advanced it, but strong resistance was met at around the svc due to tortuous anatomy.It became impossible for him to advance the system any further, and he confirmed the filter was detached and remained in the sheath.He retrieved the whole system and changed the procedure to femoral approach.Another filter inserted from the femoral was placed without problem.Patient outcome: the patient did not experience any adverse effects due to this event.

• 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: 6278355
• MDR Text Key: 65765743
• Report Number: 3002808486-2017-00118
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)141206(10)E2842749
• 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: 03/13/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2011
• 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): Required Intervention