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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 Difficult or Delayed Positioning (1157); Difficult or Delayed Activation (2577)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/10/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). 510(k): k171712. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: "jugular access. While trying to resheath the filter, patient tortuosity caused the hook to elongate and render the blue button unusable. Tried using it for a second time and the hook wouldn't go in. Couldn't use that deployment device anymore. Customer used another filter of the same gpn to complete the procedure, but did it with femoral access. " patient outcome: the complainant reported that the product did not cause or contribute to any 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 
56868686
MDR Report Key10183137
MDR Text Key199474462
Report Number3002808486-2020-00637
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/04/2020
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 NumberE3894108
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 Received06/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/05/2019
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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