MAUDE Adverse Event Report: COOK INC UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number N/A

Device Problem Crack (1135)

Patient Problems Abdominal Pain (1685); Chest Pain (1776)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.

Event Description

As reported by the fda via voluntary medwatch report mw5070240: "my name is (b)(6) sr., and i am writing you in regards to a potential ivc filter claim.I have been keeping up with all the as on tv.I have contacted several of the 1-800 numbers.(b)(4) and (b)4) have both declined to take on my claim.You have listed only two brands of ivf filter.(b)(4) law firm was working with me until i told them the name of my ivc filter.Currently we are not accepting claims relating to this filter.The name of my ivc filter is birds nest vena cava filter.I found out recently that my bird's nest vena cava filter is cracked.I have been having problems with heart and pain in my stomach.There was an x-ray that was done on my stomach and that's how we found out that the ivc filter is cracked.There are other tests that have been done and now i'm waiting on the surgery."what can you do to put this bird's nest vena cava filter on your list." i also would like to know "do you have an attorney that will work with me on this ivc filter claim." limited information has been received alleging the patient has suffered injuries.Therefore, this event will be reported under 21 cfr part 803.

Manufacturer Narrative

Investigation - evaluation a review of the complaint history, instructions for use (ifu), and quality control data was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Each device is shipped with instruction for use (ifu) t_bnf40fem_rev.1, listing the indications for use, contraindications, warnings and precautions.Per the ifu " do not use the product if there is doubt as to whether the product is sterile.Upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: UNKNOWN
• 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: 6721174
• MDR Text Key: 80285167
• Report Number: 1820334-2017-01664
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening