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 Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device under pma/510(k) k172557.Investigation is still in progress.

Event Description

Description of event according to initial reporter: sheath of igtcfs-65-jp-jug-tulip got damaged by the filter.The filter was retrieved by gtrs-200-rb but the gtrs was also damaged.The filter was placed and the procedure was completed.There have been no adverse effects to the patient reported.Additional information received 19sep2019: ivc filter placement was performed and access was gained from the right jugular vein.When the physician was advancing the introducer sheath in the body, the physician felt resistance and the sheath kinked.The sheath got damaged but the physician continued using the sheath and it reached desired position.Then, the filter catheter was delivered through the sheath.During the delivery, the filter leg was caught by the kink and the leg perforated the sheath but the physician continued using the sheath and filter.The filter reached the desired position and the physician deployed the filter but it was deployed in tilted angle.Therefore, gtrs-200-rb was used to correct the angle.Snare catheter of gtrs-200-rb advanced through the kinked sheath and corrected the angle.Filter placement was succeeded so the user attempted to remove the snare catheter to outside the body but the snare catheter was caught by the kink and the snare catheter shaft got damaged(bend).The physician somehow removed the snare catheter from the body and the procedure was completed.Patient outcome: there have been no adverse effects to the patient reported.

• 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 (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov DK-46 32; DA DK-4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 9144060
• MDR Text Key: 187997282
• Report Number: 3002808486-2019-01562
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)191216(10)E3532637
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2019
• Device Catalogue Number: IGTCFS-65-JP-JUG-TULIP
• Device Lot Number: E3532637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2016
• 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