MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER

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	08/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product issue reported (a system notice was received indicating that the refrigerant delivery path was obstructed, and a system notice was received indicating that the balloon inflation pressure was not reached in time.) is not likely to cause or contribute to a death or serious injury; however, the risk of the patient being under general anesthesia without full therapeutic effect is the adverse event being reported.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a cryo ablation procedure, a system notice was received indicating that the refrigerant delivery path was obstructed.The coaxial umbilical cable, electrical umbilical cable, catheter, and auto connection box were all replaced without resolve.The system was vented, and the case continued.However, another system notice was received multiple times indicating that the balloon inflation pressure was not reached in time.The case was aborted, and the patient was under general anesthesia.A field service visit took place on a later date, and the console was de-installed.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: data files were returned and analyzed.Data files showed that at least fourteen applications were performed with three catheters on the date of the event.A system notice indicating that the balloon inflation pressure was not reached in time (50014) was confirmed through all the applications.Also, the system notice indicating that the refrigerant delivery path was obstructed (50012) was not found through data analysis.A field service engineer tested the console and determined that it needed additional repairs.The console was de-installed.The product issue reported with system notices indicating that the balloon inflation pressure was not reached in time (50014) and the refrigerant delivery path was obstructed (50012) is not likely to cause or contribute to a death or serious injury; however, the risk of the patient being under general anesthesia without full therapeutic effect is the adverse event being reported.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.In conclusion, the system notice indicating that the balloon inflation pressure was not reached in time (50014) was confirmed through data analysis and the system notice indicating that the refrigerant delivery path was obstructed (50012) was not found through data analysis.A field service engineer tested the console and determined that it needed additional repairs.The console was de-installed.If information is provided in the future, a supplemental report will be issued.

• 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 Key: 6872459
• Report Number: 3002648230-2017-00517
• Device Sequence Number: 19012242
• Product Code: LPB
• UDI-Device Identifier: 00643169352476
• UDI-Public: 00643169352476
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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 Number: 106A3
• Device Catalogue Number: 106A3
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other