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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE APS GUNTHER TULIP IVC FILTER; FILTER, INTRAVASCULAR CARDIOVASCULAR

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WILLIAM COOK EUROPE APS GUNTHER TULIP IVC FILTER; FILTER, INTRAVASCULAR CARDIOVASCULAR Back to Search Results
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/13/2018
Event Type  Injury  
Event Description
During an ivc filter retrieval, when the filter was removed and examined, it was noticed that a small piece of one of the struts was missing.Dr looked under fluoro and the piece appeared imbedded in the vessel wall.The filter had been initially implanted in 2006.
 
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Brand Name
GUNTHER TULIP IVC FILTER
Type of Device
FILTER, INTRAVASCULAR CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE APS
MDR Report Key7922262
MDR Text Key122307225
Report NumberMW5080206
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 Nurse
Type of Report Initial
Report Date 09/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/28/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age65 YR
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