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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 Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 11/25/2014
Event Type  malfunction  
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). 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 ¿filter implanted in the wrong vein". 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). Catalog number: unknown but referred to as a cook günther tulip filter. Since catalog number is unknown the 510(k) could be either k090140, k112119 or k121057. Investigation is still in progress.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2014 (b)(4) and (b)(6) 2014 (b)(4). The filter was placed at the (b)(6) hospital in (b)(6). " patient outcome: unknown. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). Corrected data based on new information received: adverse event to product problem, serious injury to malfunction. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 04/20/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2014 due to a non-occlusive thrombus in left femoral vein resulting from being struck by a motor vehicle. Plaintiff is alleging that the filter was implanted in the wrong vein (i. E, the right iliac vein). Patient alleges successful retrieval on (b)(6) 2014 at which time another filter was implanted.
 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer Contact
thomas hessner kirk
400 daniels way
bloomington, IN 47404
8004574500
MDR Report Key5553701
MDR Text Key247559166
Report Number3002808486-2016-00163
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 08/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Date03/15/2016
Event Location No Information
Date Manufacturer Received08/15/2017
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: 04/07/2016 Patient Sequence Number: 1
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