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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G34309
Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2019
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Description of event according to initial reporter: a celect pt was prepped and followed per protocol. When it was time to deploy, the physician pressed the red button then the blue button, but the filter would not detach. Eventually it did, but the physician was not happy with the placement, so they used a retrieval set to reposition the filter. Patient outcome: no patient harm. No further action needed.

 
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Brand NameCOOK CELECT PLATINUM NAVALIGN JUGULAR 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 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key9390134
MDR Text Key184059954
Report Number3002808486-2019-01869
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,Followup
Report Date 07/28/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG34309
Device Catalogue NumberIGTCFS-65-1-JUG-CELECT-PT
Device LOT NumberE3902567
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/23/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/26/2019
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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