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

Model Number GTRS-200-RB

Device Problem Fitting Problem (2183)

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

Event Date 05/19/2016

Event Type  malfunction  

Event Description

During retrieval of ivc filter the doctor noted the outer and middle sheaths were not locking together, as if the "threads were stripped".

• Brand Name: GUNTHER TULIP VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5924160
• MDR Text Key: 53793795
• Report Number: 5924160
• 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: 07/19/2016,08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: GTRS-200-RB
• Device Catalogue Number: G13387
• Device Lot Number: E3385523
• Other Device ID Number: 6484004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2016
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2016
• 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
• Treatment: NO OTHER THERAPIES
• Patient Age: 52 YR