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); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2017

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: jugular approach was gained for filter placement.However, the sheath system could not be inserted into the patient, then deformation (curled-up) of the sheath tip was noted.Therefore, it was changed to another gunther (lot# e3493545), and the procedure was completed with the replacement device successfully.Patient outcome: there have been no adverse effects to the patient reported.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description and returned product.The complete device was returned and an investigation revealed a minor damage at the tip of the sheath, which resulted in a small gap between sheath tip and the dilator.The gap may not have precluded an advancement, but it may have caused a less smooth advancement through the skin.However, the exact reason, why "the system could not be inserted into the patient" cannot be determined.No evidence to suggest that this device was not manufactured according to specifications.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: 6841187
• MDR Text Key: 85613085
• Report Number: 3002808486-2017-01740
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)181028(10)E3380965
• 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: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• 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
• Distributor Facility Aware Date: 08/16/2017
• Device Age: 22 MO
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• 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