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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problems Aspiration/Inhalation (1725); Chest Pain (1776); Hemorrhage/Bleeding (1888); No Information (3190)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog #: unknown but referred to as a cook günther tulip filter. Expiration date: unknown as lot # is unknown. Mfr date unknown as lot # is unknown. 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. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2010. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.

 
Manufacturer Narrative

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

 
Event Description

This additional information was received on 03/22/2017 as follows: the patient allegedly received the device implant via right internal jugular vein on (b)(6) 2010 on as treatment for dvt and pe. The patient is alleging bleeding, shortness of breath, chest pain, and ringing in ears.

 
Manufacturer Narrative

Exemption number e2016032. (b)(4). Manufacturer reference #(b)(4). Corrected data based on new information received: adverse event to product problem; serious injury to malfunction. 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 "bleeding, shortness of breath, chest pain, and ringing in ears". 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.

 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
400 daniels way
bloomington, IN 47404
8004574500
MDR Report Key6344883
MDR Text Key67803104
Report Number3002808486-2017-00605
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup
Report Date 07/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date02/06/2017
Event Location No Information
Date Manufacturer Received07/04/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/21/2017 Patient Sequence Number: 1
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