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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
Catalog Number IGTCFS-65-2-UNI-CELECT-PT
Device Problems Difficult to Insert (1316); Material Perforation (2205)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(4). Catalog# igtcfs-65-2-uni-celect-pt. (b)(4). Similar to device under 510(k) k121629. Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: physicians used ivc filter with jugular deployment system. As doctor's description, the anchors were stuck at the introducer tips, so that the filter could not be withdrawn into the jugular introducer completely. When he advanced into introducer sheath, the anchors broken the sheath. 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 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 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key7482351
MDR Text Key107215290
Report Number3002808486-2018-00506
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/23/2020
Device Catalogue NumberIGTCFS-65-2-UNI-CELECT-PT
Device Lot NumberE3644715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date04/17/2018
Device Age6 MO
Event Location No Information
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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