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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 Complete Blockage (1094); Difficult to Remove (1528); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Catalog# is unknown but referred to as cook celect filter. Name and address for importer site: (b)(4). Since catalog# is unknown 510(k) could be either k061815 or k073374. (b)(4). 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.

 
Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2008". 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

Exemption number e2016032e lot. (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 06feb2018 as follows: pt allegedly received an implant on (b)(6) 2008 via the right common femoral vein due to history of deep vein thrombosis/pulmonary embolism. Pt is alleging device is unable to be retrieved. Additionally pt. Is alleging that due to a thrombosed ivc filter, stents were placed within the inferior vena cava. Pt. States was informed by md that following this procedure that the ivc filter could not be removed.

 
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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
sandet 6
bjaeverskov 4632 4632
DA   4632
56868686
MDR Report Key7141449
MDR Text Key95587147
Report Number3002808486-2017-02508
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
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup
Report Date 03/29/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Date12/06/2017
Event Location No Information
Date Manufacturer Received03/16/2018
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: 12/22/2017 Patient Sequence Number: 1
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