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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G13287
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/09/2019
Event Type  Injury  
Manufacturer Narrative

(b)(6). This report includes information known at this time. A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.

 
Event Description

It was reported, a (b)(6) male was undergoing an inferior vena cave filter removal (cook celect platinum) when the filter got stuck (endothelialized in 3 months). The snare loop from the gunther tulip vena cava filter retrieval set "broke" after it was engaged with the filter hook. The filter was not able to be removed. There has been no effect on the patient; however part of the loop remained with the filter hook after it broke.

 
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Brand NameGUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632 IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8636696
MDR Text Key145949889
Report Number1820334-2019-01280
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK073374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG13287
Device Catalogue NumberGTRS-200-RB
Device LOT NumberE3734492
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/28/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/04/2018
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: 05/23/2019 Patient Sequence Number: 1
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