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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
Model Number G34505
Device Problems Material Perforation (2205); Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2020
Event Type  Malfunction  
Manufacturer Narrative

Manufacturer ref# (b)(4). Pma/510(k): k171712. Investigation still in progress.

 
Event Description

Description of event according to initial reporter: "physician was going in with jugular access; patient had some stenosis and/or scarring, it was hard to get through. Using amplatz wire. Couldn't get filter to feed through. Physician felt obstruction or something stopping him from loading it properly. Physician stopped, pulled it out, and observed hole or puncture in the sheath that they believe was contributing to the obstruction. Physician complete procedure, unknown with what device. " how was the procedure completed? once the md realized something was wrong, he stopped and opened another filter. He as able to complete the procedure with the second device he opened. Patient outcome: the complainant reported that the product did not cause or contribute to any the adverse effects to the patient.

 
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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 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 
MDR Report Key10183025
MDR Text Key202358410
Report Number3002808486-2020-00633
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG34505
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT-PT
Device LOT NumberE3974912
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/16/2020
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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