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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CARDIOBLATE CRYOFLEX
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MEDTRONIC CARDIOBLATE CRYOFLEX Back to Search Results
Model Number 10000-04-005
Device Problem Device Inoperable (1663)
Patient Problem No Information (3190)
Event Date 08/02/2017
Event Type  Injury  
Event Description
In operating room, cryoflex was found to not be working.The operating room staff completed the self check on the unit which was fine.When the hand piece was plugged into the unit, the tip of the probe was not cooling as it should.Two other hand pieces were tried and the sales rep was called.Two issues - the argon tank attached to the cryoflex unit had a gauge/valve that was difficult to open and close the tank.The hand piece where it plugged in to the unit was loose and not sure if the connection was properly engaged.The unit was removed from the room and the sales rep was able to borrow a unit from another hospital, the argon tank was changed and the unit worked and the surgeon was able to complete the procedure.
 
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Brand Name
CARDIOBLATE CRYOFLEX
Type of Device
CARDIOBLATE CRYOFLEX
Manufacturer (Section D)
MEDTRONIC
minneapolis MA
MDR Report Key6776819
MDR Text Key82376070
Report NumberMW5071456
Device Sequence Number1
Product Code OCL
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 08/07/2017
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received08/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10000-04-005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2017
Is the Reporter a Health Professional? Yes
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) Required Intervention;
Patient Age83 YR
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