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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 Structural Problem (2506)
Patient Problems Perforation (2001); Pseudoaneurysm (2605)
Event Type  Injury  
Event Description
Description according to initial reporter: patient had a celect¿ platinum vena cava filter implanted 3 months ago.It was found that one leg had perforated the vena cava and caused a pseudoaneurysm in the lumbar artery.As the pseudoaneurysm grew the filter tilted 90 degrees (vertical to horizontal).The physician embolized (unknown coils) the lumbar artery to prevent bleeding from the pseudoaneurysm.On (b)(6) 2021, there was a failed retrieval attempt; retrieval failed due to the tilt of the filter.The physician also believes the filter migrated due to the tilt.Patient outcome: patient is asymptomatic as of (b)(6) 2022.Patient is still currently hospitalized with intention of discharge home until week of (b)(6) 2022 when the second attempt to retrieve filter will take place.
 
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Brand Name
UNKNOWN
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA  4632
MDR Report Key13384836
MDR Text Key284624986
Report Number3005580113-2022-00017
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 01/25/2022,01/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location Hospital
Date Report to Manufacturer01/25/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient SexMale
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