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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER
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MEDTRONIC CRYOCATH LP CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Model Number 106A3
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/26/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during a cryoablation procedure, a system notice was received indicating that the refrigerant delivery path was obstructed.The electrical umbilical cable, coaxial umbilical cable and catheter were replaced without resolve.The tank was replaced and system was vented.It was noted there was air 'in the lines.' the tank was reported to possibly have accumulated condensation.The case was aborted with the patient under general anesthesia.A field service visit was recommended.No further patient complications have been reported as a result of this event.
 
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Brand Name
CRYOCONSOLE
Common Device Name
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA  H9R 5Z8
MDR Report Key9071855
Report Number3002648230-2019-00659
Device Sequence Number19773489
Product Code LPB
UDI-Device Identifier00613994686077
UDI-Public00613994686077
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
P020045
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number106A3
Device Catalogue Number106A3
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/26/2019
Initial Report FDA Received Date09/16/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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