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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-2-UNI-CELECT-PT
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog #: igtcfs-65-2-uni-celect-pt. Name and address for importer site: (b)(4). Similar to device under 510(k): k121629. (b)(4). Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: release button would not release the filter; the filter would not release properly at time of deployment. The user managed to eventually deploy the filter. Patient outcome: the patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
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 Key7547978
MDR Text Key109619538
Report Number3002808486-2018-00610
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/21/2021
Device Catalogue NumberIGTCFS-65-2-UNI-CELECT-PT
Device LOT NumberE3705108
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/22/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/10/2018
Device Age2 mo
Event Location No Information
Date Manufacturer Received10/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/21/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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