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 12/24/2013

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: the tulip filter, the filter introducer and the long dilator were returned.No indications of deformations on filter or introducer.However, on the introducer sheath a kink is observed approximately 36 cm from proximal end and a penetration of sheath is noted on the opposite site in the same area.Penetration may be due to physician continued to advance though strong resistance was met, as commented by the physician and the rep.Most likely tortous anatomy caused the sheath to kink resulting in resistance during advancement.Under normal conditions the sheath is strong enough to accomplish the procedure, but the filter legs may be prone to penetrate the sheath wall, if excessive force is used to advance the filter through the kinked sheath.No evidence to suggest that 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 device was used for dvt.Since there was a cv catheter inserted in the right jugular vein, access was gained from the left jugular vein.The vessel was tortuous due to the left jugular approach.Though the physician felt resistance during advancement of the filter introducer into the sheath, he continued to advance the introducer.When the filter legs was advanced at approximately 30 cm from the hub, anchors of the filter perforated the sheath.Since there was no other stock of gunther, another manufacturer's filter (optease/ cordis) was used and the filter was placed instead.Patient outcome: there have been no adverse effects such as complications or extension of hospital stay.

• 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: 6272384
• MDR Text Key: 65573505
• Report Number: 3002808486-2017-00087
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)160820(10)E3124017
• 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: 12/25/2013

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-JP-JUG-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/25/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2013
• 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