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 Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-jp-jug-tulip.(b)(4).Similar to device under 510(k) k090140.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: access was gained from right internal jugular vein to perform ivc filter placement.The patient's anatomical forms were suitable for the procedure.While adjustment the position of the filter, the filter legs were expanded without problems.However, after the physician attempted to open/close the filter several times, the filter legs could not expand fully.Therefore, entire system was removed from the patient's body.Another manufactures' device was used instead to complete the procedure.Patient outcome: no adverse effect to the patient reported.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: since no product was returned and no imaging was provided it would be inappropriate to speculate at what may or may not have occurred based on the limited information made available to us and why the filter would no expand.However, it is noted that the filter legs were expanded without problems in the first place, but afterwards for some unknown reason attempts were made "to open/close the filter several times" and therefore it is suggested that the filter legs were crossed during said manipulation or maybe captured blood/fibrin in the legs prevented them from expanding.There is no evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.Cook medical will continue to monitor for similar events.

• Brand Name: GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 6574645
• MDR Text Key: 75418850
• Report Number: 3002808486-2017-01085
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)190907(10)E3491281
• 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,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/28/2017
• Device Age: 7 MO
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/18/2017
• Supplement Dates Manufacturer Received: 04/25/2017
• Supplement Dates FDA Received: 10/16/2017
• Date Device Manufactured: 09/07/2016
• 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