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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 Difficult to Remove (1528); Malposition of Device (2616)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/25/2022
Event Type  Injury  
Event Description
Description of event according to initial reporter: the physician was unable to snare the hook of the filter.Using right internal jugular access, the physician attempted to snare the hook of the filter which was tilted lateral within the patient, with the struts acting as a ¿backstop¿ to prop the filter at a 30-degree tilt with the hook facing medial.Physician tried to used a reverse curve catheter (c2 was all that he had in a 100 cm length) with a wire to attempt to pull the filter away from the cava wall and center it for retrieval but that was unsuccessful.Physician decided that since they didn¿t have long enough catheters at their obl, it would be best to refer the patient to another physician.There is some confusion as to when the filter was deployed.
 
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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 Key15787480
MDR Text Key303553138
Report Number3005580113-2022-00117
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 11/11/2022,11/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date10/25/2022
Event Location Hospital
Date Report to Manufacturer11/11/2022
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) Life Threatening;
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