MAUDE Adverse Event Report: COOK MEDICAL LLC GUNTHER TULIP VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number IGTCFS-65-1-JUG-TULIP

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 09/17/2020

Event Type  malfunction  

Event Description

There was movement seen of the ivc filter after deployment but before sheath was removed from body.It appeared the filter was still tethered to the deployment device.Release button was pushed multiple times before filter was released from sheath.Fda safety report id# (b)(4).

• Brand Name: GUNTHER TULIP VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK MEDICAL LLC; dk
• MDR Report Key: 10605923
• MDR Text Key: 209453137
• Report Number: MW5096953
• Device Sequence Number: 1
• Product Code: DTK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Model Number: IGTCFS-65-1-JUG-TULIP
• Device Catalogue Number: G52916
• Device Lot Number: E3938436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR