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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 Malposition of Device (2616); Activation Problem (4042)
Patient Problem Perforation of Vessels (2135)
Event Date 07/17/2015
Event Type  Injury  
Manufacturer Narrative

Manufacturer ref# (b)(4). Corrected data compared with medwatch report mw5087373: adverse event: adverse and product problem. Outcomes to adverse event: life threatening. Date of report: 18jun2019. Initial reporter: (b)(6). Initial reporter also sent report to fda: yes. Mfr contact: (b)(4). Investigation is still in progress. [(b)(4), medwatch 5087373].

 
Event Description

Description of event according to initial reporter: "ivc filter did not deploy at the correct time, causing it to deploy into a lumbar vein". Brand: cook celect platinum vena cava filter. Patient outcome: unknown.

 
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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 4632 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key8801651
MDR Text Key151430559
Report Number3002808486-2019-01007
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 HEALTH PROFESSIONAL,OTHER,USE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/2019
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2020
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: 07/18/2019 Patient Sequence Number: 1
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