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	09/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cryoablation procedure, a system notice was received multiple times indicating that the refrigerant delivery path was obstructed.All cables and the tank were disconnected and reconnected without resolve.The coaxial umbilical cable and electrical umbilical cable were replaced and the console was rebooted, all without resolve.The tank was then replaced without resolve.The system was vented and the balloon catheter was replaced, both without resolve.The case was aborted, and the patient was under general anesthesia.A field service visit on the console took place on a later date.During service, the mks valve was replaced, and the console passed full inspection.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: data files were returned and analyzed.The data files showed that three applications were performed with the balloon catheter and seventeen on another balloon catheter on the day of the event.Also, a system notice indicating that the refrigerant delivery path was obstructed (#50012) was triggered on multiple applications.The field service engineer reported that the mks valve was replaced.The console was tested after repairs and deemed appropriate for clinical use.The product issue reported (#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.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: 6936601
• Report Number: 3002648230-2017-00555
• Device Sequence Number: 16439803
• Product Code: LPB
• UDI-Device Identifier: 00613994686077
• UDI-Public: 00613994686077
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/07/2017

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: 09/19/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 11/07/2017
• 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