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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 Fracture (1260); Appropriate Term/Code Not Available (3191); Migration (4003)
Patient Problems Internal Organ Perforation (1987); Pain (1994); Bowel Perforation (2668)
Event Date 12/17/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: as reported to customer relations "the patient presented with back pain. A ct scan revealed one of the primary legs of the filter had migrated into a vertebral body and an additional leg had migrated into the duodenum. Also revealed on the scan was discontinuation of a secondary leg and a leg was fractured. The filter was retrieved. Upon retrieval and analysis of the filter, it was revealed that all of the filter was accounted for except for a 1 cm portion of a secondary leg. Retrieval of the 1 cm segment was attempted but was unsuccessful. Patient outcome: did any unintended section of the device remain inside the patient¿s body? yes: 1 cm. Portion of a secondary leg -ct and filter retrieval attempt. Did the patient require any additional procedures due to this occurrence? yes: ct and filter retrieval attempt. Did the product cause or contribute to the need for additional procedures? yes: ct and filter retrieval attempt. Has the complainant reported any adverse effects on the patient due to this occurrence? yes. Has the complainant reported that the product caused or contributed to the adverse effects? yes: back pain and fluid collection in duodenum around leg fragment that is possibly infected. Did the penetration/perforation cause trauma/damage to any adjacent structures? yes: bone calcification around leg extending into vertebral body and fluid collection around secondary leg in duodenum. Did the penetration/perforation cause any hematoma? slight contained caval tear.
 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key8221938
MDR Text Key132218003
Report Number3002808486-2019-00020
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 Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date12/18/2018
Event Location No Information
Date Manufacturer Received01/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/07/2019 Patient Sequence Number: 1
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