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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 Appropriate Term/Code Not Available (3191); Migration (4003)
Patient Problems Pain (1994); Perforation of Vessels (2135); Disability (2371)
Event Type  Injury  
Event Description

It is alleged that the patient received a cook celect filter on or about (b)(6) 2008. Also alleged: "on or about (b)(6) 2017, it was discovered that the cook filter struts had moved since the filter was placed, with several struts perforating outside of the patient's inferior vena cava. " hospital and medical records have been requested but not yet provided.

 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
MDR Report Key9071213
MDR Text Key160724084
Report Number3005580113-2019-00390
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 Distributor
Reporter Occupation
Type of Report Initial
Report Date 09/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/16/2019
Distributor Facility Aware Date08/22/2019
Event Location Other
Date Report TO Manufacturer08/21/2019
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: 09/16/2019 Patient Sequence Number: 1
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