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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK MEDICAL 001 GUNTHER TULIP VENA CAVA FILTER FEMORAL APPROACH

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COOK MEDICAL 001 GUNTHER TULIP VENA CAVA FILTER FEMORAL APPROACH Back to Search Results
Model Number IGTCFS-65-1-FEM-TULIP
Device Problem Crack (1135)
Patient Problem No Information (3190)
Event Date 01/27/2014
Event Type  Injury  
Event Description

While using the coaxial introducer sheath system, the physician noticed a crack in the hub, during insertion into the patient. Reason for use: angio suite cardiac intervention. Event abated after use stopped or dose reduced: yes. This product also has this listed on the wrapper: (b)(4).

 
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Brand NameGUNTHER TULIP VENA CAVA FILTER FEMORAL APPROACH
Type of DeviceVENA CAVA FILTER FEMORAL
Manufacturer (Section D)
COOK MEDICAL 001
bloomington IN 47402
MDR Report Key3619214
MDR Text Key21730505
Report NumberMW5034230
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/04/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/05/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIGTCFS-65-1-FEM-TULIP
Device LOT NumberE3104715
OTHER Device ID NumberG52917
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? Yes

Patient TREATMENT DATA
Date Received: 02/05/2014 Patient Sequence Number: 1
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