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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-JUG-TULIP
Device Problem Premature Separation (4045)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2020
Event Type  Malfunction  
Manufacturer Narrative

Manufacturer ref# (b)(4). Occupation: clinical lead. Pma/510(k) k172557. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: on (b)(6) 2020 - physician used an ivc filter on saturday, the first one ((b)(4)) deployed while physician was inserting it, the button was not deployed. The second one ((b)(4)) deployed in the catheter in the body, which had to be retrieved with an ensnare and then redeployed. 2 different lot numbers. On (b)(6) 2020 - we were placing a tulip filter ((b)(4)) from the internal jugular. I inserted the sheath and pulled the introducer and wire out. I was getting ready to load the filter in the sheath and when physician handed me the catheter with the filter loaded in it the filter popped out onto the table. The physician said he did not deploy the filter and did not press the safety button. Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
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Brand NameGUNTHER TULIP 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
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 
56868686
MDR Report Key9784815
MDR Text Key182972187
Report Number3002808486-2020-00268
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 08/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-1-JUG-TULIP
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/04/2020 Patient Sequence Number: 1
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