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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 to Insert (1316); Material Perforation (2205)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Implant date: (b)(6) 2018. Explant date: (b)(6) 2018. Name and address for importer site: (b)(4). Corrected data compared with medwatch report: event date: (b)(6) 2018. Date of this report: feb2018. Brand name: cook celect. Common name: filter, intravascular, cardiovascular. Mfr: (b)(4). G34505. User facility (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to medwatch (b)(4): inferior vena cava (ivc) filter sheath placed in left femoral vein. Upon insertion of ivc filter deliver system under fluoroscopy, the device was seen to have gone through the sheath wall. Entire system removed un-deployed. New device successfully deployed. Faulty device saved, bagged, and the product representative notified. Left groin stable, no hematoma, patient to recovery in stable condition. Intended procedure: inferior vena cava (ivc) filter placement for bilateral deep vein thrombosis(dvt) with pulmonary embolism (pe) contraindication to anticoagulation. Patient outcome: stable condition.
 
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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 Key7836316
MDR Text Key119212712
Report Number3002808486-2018-00985
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Risk Manager
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 Received08/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/11/2020
Device Model NumberG34505
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT-PT
Device Lot NumberE3640455
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date08/17/2018
Device Age4 MO
Event Location No Information
Date Manufacturer Received10/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2017
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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