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 Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: the received images show that the introducer sheath is kinked and penetrated.The secondary filter legs are curled around the primary filter legs.Under normal conditions the introducer sheath system is strong enough to accomplish the procedure, but it has been seen before that if the sheath is somehow exposed to excessive force because of tortuous anatomy, this kind of problem may occur.With a reference to our instruction for use, section ¿warnings, filter placement,¿ it says:¿ excessive force should not be used to place the filter.¿ cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: the device was used for ivc filter placement.The physician inserted the sheath from the right jugular vein and placed it in inferior vena cava.Then, he attempted to advance the filter introducer into the sheath, but the filter got stuck on the sheath near the approach point.Although the physician tried to withdraw the filter, it did not move.After several attempts of withdrawing the filter, the filter was released in the sheath and only the filter introducer was removed from the sheath.After that, the physician attempted to pull the whole sheath system out, but it could not be withdrawn.Another filter (femoral vein approach) was replaced, then placed successfully.The sheath system remained in the vein is to be retrieved by surgical operation on (b)(6) 2012.Additional information received 09apr2012: the sheath system was retrieved successfully by surgical operation on (b)(6) 2012.Patient outcome: patient not recovered.Additional information received 09apr2012: the patient recovered.There have been no adverse effects.

• 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: 6306666
• MDR Text Key: 66657993
• Report Number: 3002808486-2017-00263
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)150111(10)E2858355
• 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: 04/05/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2012
• Date Device Manufactured: 01/11/2012
• 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
• Patient Outcome(s): Required Intervention