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 09/18/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.Summary of investigational findings: the jugular introducer and sheath are returned.No filter returned.The sheath has two kinks, a smaller one 15 cm proximally and a somewhat larger 30 cm proximally.Apart from the two kinks the sheath appears normal and no sheath perforations.Based on the information provided, it is not possible to conclude an exact root cause for the reported "filter introducer would not advance through the sheath." however, it is possible that the patient anatomy reported caused sheath to kink and that was the reason the introducer would not advance through the sheath.Under normal circumstances the sheath is strong enough to accomplish the procedure, however if excessive force is used to advance the sheath through tortuous anatomy it may kink.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: an ivh catheter was placed in the right jugular vein so the device was introduced via the left jugular vein.The access vessel had moderate tortuosity.After the sheath was advanced to the target site, the filter introducer was inserted into the sheath but it became stuck around the subclavian vein.Upon removal of the delivery system, it was found that the filter was caught on the sheath.Another device was used instead for the procedure.Patient outcome: no adverse effect to 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: 6299348
• MDR Text Key: 66563445
• Report Number: 3002808486-2017-00245
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)150621(10)E2938075
• 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: 09/20/2013

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: 09/20/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2012
• 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