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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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WILLIAM COOK EUROPE COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G48378
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Event or Problem Description
It is alleged that "[pt] received a cook celect filter on (b)(6) 2012.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".
 
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Brand Name
COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER
Common Device Name
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA  4632
MDR Report Key9445736
Report Number3005580113-2019-00872
Device Sequence Number11323509
Product Code DTK
UDI-Device Identifier00827002483781
UDI-Public(01)00827002483781(17)140706(10)E2943419
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Reporter Type Importer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/10/2019
Report Date (Section F) 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date07/06/2014
Device Model NumberG48378
Device Catalogue NumberIGTCFS-65-UNI-CELECT-PERM
Device Lot NumberE2943419
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date12/10/2019
Event Location Other
Date Report to Manufacturer12/09/2019
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/10/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Life Threatening;
Date Report Sent to FDA12/10/2019
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