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

Model Number	106A3
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2018
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 cryo ablation procedure, the temperature was not as expected.Additionally, a system notice was received indicating that the refrigerant delivery path was obstructed.The error was attempted to be cleared without resolve.The coaxial umbilical cable was reconnected several times without resolve.The electrical umbilical cable was replaced, all connections were checked, and the console was restarted, with no success.The catheter was also tested out of the patient body with no resolve.The procedure was aborted due to impossibility of console operation, and the patient was under general anesthesia.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Event summary: the patient data files showed at least four injections were performed with catheter 2af283/35145 on the date of the event; system notice (#50012) indicating that the refrigerant delivery path was obstructed was triggered on application one, three, and four.The returned failure file showed system notice #50012 ¿the refrigerant delivery path is obstructed¿ was triggered multiple times.Power up file information is not relevant to the reported issue.In conclusion, the reported the system notice #50012 ¿the refrigerant delivery path is obstructed¿ was confirmed through the date analysis.The reported temperature issue cannot confirm the data analysis.This report will be recorded and trended.Possible malfunction cannot be identified with clinical data analysis only.The product issues reported (system notice 50012, temperature) are 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: 7534179
• Report Number: 3002648230-2018-00330
• Device Sequence Number: 19256617
• Product Code: LPB
• UDI-Device Identifier: 00643169449596
• UDI-Public: 00643169449596
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P020045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2018

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: 04/30/2018
• Supplement Date Received by Manufacturer: 06/27/2018; 07/25/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/28/2018; 08/20/2018
• 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
• Patient Age: 39 YR
• Patient Weight: 83