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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 Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/21/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Pma/510(k) k171712. Investigation is still in progress. This report is required by the fda under 21 cfr part 803. This report is based on unconfirmed information submitted by others. Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Event Description
Description of event according to initial reporter: while attempting to deploy a celect filter on sat (b)(6) 2021, the filter went through the side of the blue sheath that is included with the set. Fortunately the physician was able to retract the filter back into the sheath and pull both the filter and the blue sheath out. The filter was damaged in the process but was fortunately fully intact. The hospital saved the damaged filter. After this incident the physician immediately opened a second cook celect filter and successfully placed the second filter in the patient without incident. Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence. The patient did not require any additional procedures 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, dk-4632
bjaeverskov
Manufacturer Contact
lissi walmann
sandet 6, dk-4632
bjaeverskov 
56868686
MDR Report Key12458733
MDR Text Key271046681
Report Number3002808486-2021-01783
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG34505
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT-PT
Device Lot NumberE4099835
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received12/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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