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 Leak/Splash (1354)

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

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-jp-jug-tulip.Similar to device under 510(k): k090140.(b)(4).Summary of investigational findings: the investigation did not reveal any leakage from the sheath.According to the description the stopcock was connected to the hub.Also physician and sales rep comment on either the stopcock or the sheath had a crack/slit.However, the stopcock was not returned for investigation and no crack or slit was found on the returned sheath.Therefore the root cause 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.

Event Description

Description of event according to initial reporter: the sheath and dilator were inserted by jugular approach and advanced to the target site.A stopcock contained in the gunther set was connected to the hub and a syringe was attached to the stopcock.When the user pulled the plunger of the syringe to fill the sheath with blood, air was aspirated into the syringe.Though air was aspirated at every attempt, filter introducer was advanced into the sheath to perform filter placement.However because air was confirmed again, the physician decided to stop using the device and attempted to remove the filter introducer from the patient.Then, anchors of the filter legs were caught on the edge of the sheath.The sheath was not fully withdrawn but just up to the puncture site not to damage the puncture site with the exposed anchors and not to let the filter travel and be placed in undesired site.Then, the sheath outside the patient was cut off by the user near the point where the filter appeared to lodge.Since the filter became visible and touchable, the legs were closed by the user and the filter could be removed.After that, the remained section of the sheath was removed as well.Another device was used instead and the filter was placed with no air aspiration during the procedure.Patient outcome: the patient had a favorable outcome.

• 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: 6272435
• MDR Text Key: 65580041
• Report Number: 3002808486-2017-00074
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)180303(10)E3308629
• 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: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• 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: 08/11/2015
• Date Device Manufactured: 03/03/2015
• 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