MAUDE Adverse Event Report: WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FEMORAL APPROACH; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-JP-FEM-TULIP

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2012

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-jp-fem-tulip.Similar to device under 510(k) k090140.Summary of investigational findings: according to the description, the device was inserted via left femoral vein and the sheath was thought to be damaged due to tortuous vessel according to physician`s comment.Under normal conditions the sheath is strong enough to accomplish the procedure.It is seen before, that if the sheath somehow is exposed to extensive force because of tortuous anatomy, this kind of problem may occur.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: the physician used igtcfs-45-fem for ivc filter placement.Left femoral vein approach was selected since jugular vein of the patient could not be punctured and there was blood clot in right iliac-femoral veins of the patient.The delivery sheath of the igtcfs-45-fem was advanced to the ivc by left femoral approach and then the angiography of the ivc was performed.After the position of the renal vein was confirmed, the physician inserted the filter introducer into the sheath.However, he encountered resistance when advancing the filter introducer.It got stuck in the sheath and did not advance.He retrieved the whole system from the patient's body since he thought that if he pushed it with force, the filter could be deformed.The retrieved system was checked and it was confirmed that the delivery sheath was kinked.Another temporary filter was placed in ivc with left femoral approach and the procedure was completed.Additional information provided 19jul2013: correct rpn: igtcfs-65-jp-fem-tulip.Patient outcome: there have been no adverse effects to the patient.

• Brand Name: GÜNTHER TULIP VENA CAVA FEMORAL 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: 6278353
• MDR Text Key: 65772398
• Report Number: 3002808486-2017-00141
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037755
• UDI-Public: (01)00827002037755(17)140615(10)E2759290
• 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: 07/13/2012

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-JP-FEM-TULIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2012
• Date Device Manufactured: 06/01/2011
• 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