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

Catalog Number IGTCFS-65-FEM

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook gunther tulip filter.(b)(4).It has not been possible to investigate or evaluate this alleged 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.

Event Description

Description of event according to short form complaint filed: it is alleged that "patient received a cook gunther tulip filter on (b)(6) 2011".Patient outcome: it is alleged that patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Exemption number e2016032e lot.(b)(4).Additional information provided determined that this device was manufactured by cook inc.With the submission of this follow up report, william cook europe informs that this complaint has been transferred from william cook europe to cook inc.(b)(4).

• 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 Contact: thomas hessner kirk ; sandet 6; dk-4632 bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 7132849
• MDR Text Key: 95322807
• Report Number: 3002808486-2017-02476
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• 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: 03/01/2018

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: IGTCFS-65-FEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/06/2017
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 03/01/2018
• Date Device Manufactured: 03/29/2011
• 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): Life Threatening