MAUDE Adverse Event Report: COOK MEDICAL LLC COOK MEDICAL; IVC FILTER

Model Number G34505

Device Problems Premature Activation (1484); Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2018

Event Type  Injury  

Event Description

The ivc filter was inserted and was noted that the filter had partially expanded and wedged in an ancillary vein off of the ivc prior to deployment.Ivc filter was retrieved with a snare and removed without complication.A new ivc filter was placed in the ivc with no complications.

• Brand Name: COOK MEDICAL
• Type of Device: IVC FILTER
• Manufacturer (Section D): COOK MEDICAL LLC; bloomington IN 47402
• MDR Report Key: 7366103
• MDR Text Key: 103462291
• Report Number: MW5076059
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• 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: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3687040
• Was Device Available for Evaluation?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 93