MAUDE Adverse Event Report: COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-JUG

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: lead tech.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during placement of an inferior vena cava filter using gunther tulip jugular vena cava filter set, it seemed as if the sheath and filter were still connected after filter deployment and retraction of the delivery sheath.As the physician pulled the device back, the filter moved in the direction of the sheath.The user then advanced the sheath and catheter beyond the apex of the filter and attempted retraction, at which point the sheath and catheter withdrew without being connected to the filter.The filter was placed in the intended location, oriented properly head-to-toe without tilt, and the procedure was completed successfully with the complaint device.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

Additional information regarding the device was received 02aug2021.The complaint device was not manufactured by cook incorporated.

Manufacturer Narrative

Product information was received 02aug2021.The compliant device is igtcfs-65-1-jug-tulip, which is not manufactured by cook incorporated (cinc).Therefore, this complaint is not reportable by cinc.The manufacturer for the device (william cook europe) has been notified and all further reporting requirements will be the responsibility of wce.Additional/corrected information: b5, d1, d3, d4.D1: gunther tulip navalign jugular vena cava filter set.D3: william cook europe.D4: igtcfs-65-1-jug-tulip.

• Brand Name: GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12167366
• MDR Text Key: 261536766
• Report Number: 1820334-2021-01798
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K072240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR