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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Disability (2371)

Event Type  malfunction  

Manufacturer Narrative

Manufacturer pr# (b)(4).William cook europe initially reported event under mfr report # 3002808486-2016-01412.New information was received identifying that the product was a cook inc.Manufactured device.(b)(4).The event is currently under investigation; a supplemental report will be submitted upon completion.

Event Description

It is alleged that "[pt] received a gunther tulip filter on (b)(6) 2012.It is alleged that the filter is unable to be retrieved without further details provided.It was reported that the patient is experiencing pain, suffering and disability.

Manufacturer Narrative

This report is a duplicate of the report submitted with medwatch report on 10nov2017.The report was incorrectly submitted as follow up #2.No additional information was provided or further investigation was conducted.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Cook inc previously submitted follow up 1 incorrectly.Cook inc.Is submitting thir follow up as a correction.

• Brand Name: GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6405575
• MDR Text Key: 69993568
• Report Number: 1820334-2017-00569
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330167
• UDI-Public: (01)10827002330167(17)140601(10)2776742
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IGTCFS-65-FEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2017
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 69 YR
• Patient Weight: 136