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

Model Number	106A3
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the data files were returned and analyzed.The data files indicated the electrophysiology (ep) catheter 227f3 with lot number 872218 was used for one application and system notice 50005, indicating that the safety system detected fluid in the catheter and stopped the injection, was received.In conclusion, the reported system notice 50005, indicating that the safety system detected fluid in the catheter and stopped the injection, 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.
Event or Problem Description
It was reported that during a cryo ablation procedure, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.The coaxial umbilical cable, electrical umbilical cable and electrophysiology (ep) catheter were replaced, and the console was rebooted, without resolve.Another system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.The same products were replaced without resolve.The case was aborted with the patient under general anesthesia.No further patient complications have been reported as a result of this event.

• 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: 8760423
• Report Number: 3002648230-2019-00474
• Device Sequence Number: 2040191
• Product Code: LPB
• UDI-Device Identifier: 00643169449596
• UDI-Public: 00643169449596
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 07/03/2019

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 Number: 106A3
• Device Catalogue Number: 106A3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 07/03/2019
• 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