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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 N/A
Device Problems Material Separation (1562); Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device has been requested and not yet received. The event is currently under investigation.

 
Event Description

A gunther tulip vena cava filter retrieval set was used during a filter retrieval procedure. It was reported that the filter retrieval was successful. However, when preparing for the post vena cavagram, the doctor "flicked" the sheath with his finger to remove any air bubbles trapped within, causing the valve to separate from the sheath. The doctor was not able to take a post venacavagram because of this; however the case was completed. No unintended section of the device remained inside the patient's body and no adverse effects on the patient were reported 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 Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6785657
MDR Text Key82681117
Report Number1820334-2017-02487
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,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/10/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberGTRS-200-RB
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/31/2017
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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