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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-UNI-TULIP
Device Problems Structural Problem (2506); Detachment of Device or Device Component (2907); Unintended Movement (3026)
Patient Problems Abdominal Pain (1685); Internal Organ Perforation (1987); Atrial Perforation (2511)
Event Date 07/24/2020
Event Type  Injury  
Manufacturer Narrative

Manufacturers ref# (b)(4). Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: partially successful retrieval of a tulip placed 6/7 years ago. One primary strut had fractured and penetrated the aorta. A separate piece of secondary strut was seen just to the right of that. The main body was still intact, however, the hook was embedded in the caval wall and a primary strut attached to the filter's main body had penetrated the duodenum causing the patient abdominal pain. We were able to separate the filter hook from the wall using the loop snare technique then with the 9fr sheath from the gtrs set for added support inside the 16fr x 45 performer sheath used with blunt force to get the legs off the wall and cover the filter for successful retrieval. Due to caval spasm and significant fibrin covering the fractured leg, we were unable to retrieve it, but doc may bring patient back for another attempt once the cava returns to normal. Successful case due to the fact we were able to retrieve the main body of the filter and relieve the patient's abdominal pain. Patient outcome: there is an unintended section of the device remained inside the patient¿s body. The perforated duodenum caused the patient abdominal pain.

 
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Brand NameGUNTHER TULIP NAVALIGN JUGULAR & FEMORAL 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 Key10383509
MDR Text Key202369112
Report Number3002808486-2020-00754
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
Report Date 08/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-1-UNI-TULIP
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2020
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: 08/10/2020 Patient Sequence Number: 1
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