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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK COOK GUNTHER TULIP IVC FILTER

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COOK COOK GUNTHER TULIP IVC FILTER Back to Search Results
Model Number GUNTHER TULIP
Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Tip (3123)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/05/2017
Event Type  Injury  
Event Description

The patient had a cook gunther tulip ivc filter placed in 2002 after trauma. He presented for retrieval in 2017 and it was determined the filter was tip embedded fractured and a piece had migrated to the pulmonary artery. The filter was removed. There is 1 small piece left in the extravascular space near the ivc. There is a second small piece in a branch of the right pulmonary artery. The plan will be to attempt at removal of that piece in the near future.

 
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Brand NameCOOK GUNTHER TULIP
Type of DeviceIVC FILTER
Manufacturer (Section D)
COOK
IN
MDR Report Key7101142
MDR Text Key94390859
Report NumberMW5073856
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/06/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberGUNTHER TULIP
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/07/2017 Patient Sequence Number: 1
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