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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
Model Number G52916
Device Problems Material Puncture/Hole (1504); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/05/2019
Event Type  Malfunction  
Manufacturer Narrative

Manufacturer ref# (b)(4). Occupation: senior perioperative cost specialist. Pma/510(k): k172557. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: "filter hooked into side of sheath. " the filter did not pass smoothly through the sheath but instead got stuck partway in and this resulted in a hole in the side of the sheath. Physician was able to massage the sheath and pass the filter past the hole in the sheath and deploy it uneventfully. No bad patient outcome, just the filter getting stuck and that causing a hole in the sheath. Physician placed it the way he have done hundreds of times, without a kink in the sheath that might explain this. 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 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 Key9127380
MDR Text Key160391034
Report Number3002808486-2019-01547
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,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/27/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG52916
Device Catalogue NumberIGTCFS-65-1-JUG-TULIP
Device LOT NumberE3831778
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/04/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/14/2019
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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