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

Catalog Number UNKNOWN

Device Problems Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Internal Organ Perforation (1987); Anxiety (2328); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

Event Description

This additional information received on 9feb2018 as follows: ¿[pt] allegedly received an implant on (b)(6) 2005 via the right internal jugular vein due to pulmonary embolism with prior knee replacement. [pt] is alleging tilt, organ perforation-mesenteric. [pt] further alleges anxiety/stress. There are no filter retrieval attempts.

Manufacturer Narrative

Investigation - it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating "gunther tulip filter implanted. " 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.

Manufacturer Narrative

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

Event Description

It is alleged that the plaintiff received a gunther filter on (b)(6) 2005. It is alleged that the plaintiff was injured without further explanation. Hospital and medical records have been requested but not yet provided.

• 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: 7125115
• MDR Text Key: 253556324
• Report Number: 1820334-2017-04436
• 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,Followup,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/18/2017 Patient Sequence Number: 1