MAUDE Adverse Event Report: COOK GUNTHER TULIP; VENA CAVA FILTER

Lot Number G52916

Device Problem Separation Failure (2547)

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

Event Date 10/06/2015

Event Type  malfunction  

Event Description

After unsheathing the filter, the tip of the filter would not release/detach.

• Brand Name: GUNTHER TULIP
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): COOK
• MDR Report Key: 5273124
• MDR Text Key: 33007273
• Report Number: MW5058344
• Device Sequence Number: 1
• Product Code: DTK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: G52916
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR