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 Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2013

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: investigation of returned device confirms that sheath is kinked and perforated.Filter appears fine.Under normal conditions the sheath is strong enough to accomplish the procedure, but it is seen before that the sheath may kink if somehow exposed to excessive force because of tortuous anatomy.If the filter is advanced through a kinked sheath, the filter legs may be prone to exceed the sheath wall.In this case it is concluded that the damages observed to the device is a consequence of tortuous patient anatomy and following resistance during insertion.No evidence to suggest that product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: a patient experienced ivc filter placement with igtcfs-65-jp-jug-tulip.After right jugular vein was punctured, the sheath system was advanced to the target site successfully.However, since the curve of the neck vein was steep, the filter leg perforated the sheath when advancing the filter catheter ((b)(4)).The device was retrieved and replaced with another igtcfs-65-jp-jug-tulip ((b)(4)).However, this second filter catheter got stuck in the sheath and could not be passed through the sheath.Puncture site was changed and another manufacture's temporary filter was placed.Additional information received 27feb2013: when puncturing was conducted, the angle of the puncturing was almost 90° and the sheath got kinked.However, the physician did not notice the fact and advanced the filter, so the filter leg might have perforated the sheath.In addition, the physician did not change the angle/site of puncturing when using the second igtcfs-65-jp-jug-tulip.Therefore, it might not have passed through the sheath.Patient outcome: no information provided.

• 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: 6299238
• MDR Text Key: 66468113
• Report Number: 3002808486-2017-00229
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)150906(10)E2974729
• 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: 02/22/2013

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-JP-JUG-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2012
• 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