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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G34502
Device Problems Mechanical Problem (1384); Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/20/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Occupation: non-healthcare professional. Name and address for importer site: (b)(4). Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: "the filter was placed into the sheath, and physician felt resistance as she was advancing the filter thru the sheath. She pulled back and realized the filter was damaged. A new filter was opened and used to complete the procedure. " 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 FEMORAL 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 Key7875902
MDR Text Key120249381
Report Number3002808486-2018-01097
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121629
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 11/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/14/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG34502
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Device LOT NumberE3712145
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/11/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date08/29/2018
Device Age4 mo
Event Location No Information
Date Manufacturer Received10/31/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/12/2018
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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