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

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problems Pain (1994); Disability (2371)

Event Type  malfunction  

Manufacturer Narrative

William cook (b)(4) initially reported event under mfr report # 3002808486-2016-01341.New information was received identifying that the product was a cook inc.Manufactured device.(b)(4).The event is currently under investigation.

Event Description

It is alleged that a patient received a gunther tulip filter on (b)(6) 2010.It is alleged that the device is unable to be retrieved without further details.It was reported that the patient experienced pain, suffering and disability.

Manufacturer Narrative

According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e.G., the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu.It has not been possible to fully investigate or evaluate this event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

Patient allegedly received an implant on (b)(6) 2010 due to pulmonary embolisms and deep vein thrombosis.

Manufacturer Narrative

Investigation ¿ investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported pain and disability are directly related to the filter and unable to identify a corresponding failure mode at this time.The following allegations have been investigated: pain, disability.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received.Product is manufactured, inspected and packaged by william cook (b)(4).

Event Description

No additional information provided at this time.

• 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 ; 8123392235
• MDR Report Key: 6408283
• MDR Text Key: 70056036
• Report Number: 1820334-2017-00572
• Device Sequence Number: 1
• Product Code: DTK
• 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: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: Not provided; 03/20/2019; 06/23/2019
• Supplement Dates FDA Received: 05/30/2017; 04/12/2019; 07/19/2019
• Date Device Manufactured: 03/24/2010
• 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): Life Threatening
• Patient Weight: 75