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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Pain (1994); Perforation of Vessels (2135); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The event is currently under investigation.A supplemental report will be submitted upon completion.

Event Description

It is alleged that [pt] received a cook gunther tulip on (b)(6) 2004.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Unknown if the following patient and device codes are listed in the ifu.Product information not provided.(b)(4).Corrected data based on new information received: adverse event to product malfunction.Serious injury to malfunction.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.The event is currently under investigation.A supplemental report will be provided upon conclusion.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.Unknown if the following patient and device codes are listed in the ifu.Product information not provided.(b)(4).Corrected data based on new information received: adverse event to product malfunction.Serious injury to malfunction.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 06/21/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2004 via the right femoral vein due to bilateral pe and dvt in right femoral and popliteal veins.Plaintiff is alleging edema, pain, swelling, stiffness, vena cava perforation, and inability to stand for long periods.

• 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: 6601496
• MDR Text Key: 76307096
• Report Number: 1820334-2017-01096
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/10/2017
• Date Manufacturer Received: 06/21/2017
• 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
• Patient Weight: 159