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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 Problems Difficult to Remove (1528); Activation Problem (4042)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative

Manufacturer ref# (b)(4). Blank fields on this form indicate the information is unknown or unavailable. Occupation: non-healthcare professional. Pma/510(k) k172557. (b)(4). Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: we received information on 02dec2019 that shows that there were two devices involved in the implant and one had to be removed. The ivc was patent with normal configuration and caliber and was free of thrombus. The initial inferior vena cava filter failed to deploy properly and had to be recovered. This recovery was complicated by laceration to the inferior cava which was treated by balloon tip not. The level of the renal veins was noted. The inferior vena cava filter was deployed in the infrarenal inferior vena cava. Patient outcome: follow up intervening cavogram demonstrated no active extravasation of contrast. A new inferior vena cava filter was deployed.

 
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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 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key9443363
MDR Text Key178333525
Report Number3002808486-2019-01949
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,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/10/2019
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 Received07/28/2020
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: 12/10/2019 Patient Sequence Number: 1
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