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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 Problem Great Vessel Perforation (2152)
Event Date 07/13/2021
Event Type  Injury  
Event Description
According to the initial reporter, "i supported a filter retrieval yesterday at an obl and originally thought the filter was an option elite, but upon further evaluation, it appears to be a cook celect (not platinum) that was implanted 10 years ago.The filter has significant penetration through the ivc wall and abutted the aorta, we were unable to retrieve it and a second attempt will be made at the hospital with forceps and if unsuccessful, the patient will be referred to a specialist.".
 
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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 Key12279997
MDR Text Key265137917
Report Number3005580113-2021-00095
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 Physician
Type of Report Initial
Report Date 08/03/2021,08/05/2021
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
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date07/13/2021
Event Location Hospital
Date Report to Manufacturer08/03/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/05/2021
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) Required Intervention;
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