MAUDE Adverse Event Report: COOK INC GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number BNF-40-PB

Device Problem Insufficient Information (3190)

Patient Problems Thrombus (2101); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

William cook europe initially reported event under mfr report # 3002808486-2016-00742.New information was received identifying that the product was a cook inc.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

Patient was allegedly treated for blood clots and claims to have received a birds nest implant on (b)(6) 1999.Patient is alleging bleeding, clots in lungs and veins.

Manufacturer Narrative

It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.

• Brand Name: GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6477491
• MDR Text Key: 72289653
• Report Number: 1820334-2017-00788
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 07/17/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: BNF-40-PB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/09/2016
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 04/10/2017
• Supplement Dates Manufacturer Received: 06/29/2017
• Supplement Dates FDA Received: 07/17/2017
• Date Device Manufactured: 05/11/1999
• 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 Age: 49 YR
• Patient Weight: 134