MAUDE Adverse Event Report: COOK, INC. GUNTHER TULIP; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G52918

Device Problems Bent (1059); Break (1069)

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

Event Date 03/30/2018

Event Type  malfunction  

Event Description

Upon positioning the device within the patient, it was noticed the filter was damaged/misshapen.The support legs of the filter were bent in an upward position.When this was noticed, the filter was unable to be removed.The filter was then deployed in the inferior vena cava.After this the doctor then retrieved this filter from a jugular approach.After the retrieval was successfully performed, another filter was placed into the inferior vena cava without difficulty.Manufacturer response for gunther tulip vena cava filter, gunther tulip vena cava filter (per site reporter): vendor will retrieve the device from the facility and perform an evaluation.

• Brand Name: GUNTHER TULIP
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7618960
• MDR Text Key: 111733698
• Report Number: 7618960
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/21/2021
• Device Model Number: G52918
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Device Lot Number: E3692849
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 94 YR
• Patient Weight: 75