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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 Code Available (3191)
Event Date 08/31/2018
Event Type  Injury  
Manufacturer Narrative

No code available ((b)(4)) for intervention to retrieve the broken snare. 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, during a filter retrieval procedure, the proximal end of the snare portion of the gunther tulip vena cava filter retrieval set broke. There was no harm to the patient. The physician removed the device and used another of the same type. Reportedly, no resistance was felt; however, the filter was not able to be retrieved. Reportedly, the filter had been in place for six weeks. A section of the device did not remain inside the patient¿s body. 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 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 Key7891176
MDR Text Key120822132
Report Number1820334-2018-02765
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 11/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/19/2018
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 Number8698129
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/07/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/31/2018
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: 09/19/2018 Patient Sequence Number: 1
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