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U.S. Department of Health and Human Services

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

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COOK INC 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 No Known Impact Or Consequence To Patient (2692)
Event Date 10/03/2018
Event Type  Malfunction  
Manufacturer Narrative

This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.

 
Event Description

It was reported, a male patient approximately in his 50's, underwent an inferior vena cava (ivc) filter retrieval procedure where a gunther tulip vena cava filter retrieval set was used. Access was gained using a micropuncture set. A guidewire was inserted into the ivc and a flush catheter was inserted. A venogram was performed, the complaint device inserted over the wire and the filter was snared. While retracting the filter into the 9fr inner sheath using mild force, the outer 11fr sheath partially separated. Nothing detached in the patient. The physician was able to remove the entire system with the filter from the patient's anatomy. A section of the device did not remain inside the patient¿s body. There was no harm to the patient and no need for any additional procedures. The filter had been in place approximately two years. No other devices were used during the removal of the cook tulip ivc filter.

 
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Brand NameGUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington 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 Key7992385
MDR Text Key126229190
Report Number1820334-2018-03153
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK073374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/22/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG13287
Device Catalogue NumberGTRS-200-RB
Device LOT Number9036519
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/11/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/03/2018
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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