MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	227F3
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
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, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.Additionally, it was observed that there was blood on the coaxial umbilical cable.Both coaxial cable and therapy catheter were replaced with resolve.It was also reported that a system notice was received indicating that the system detected a software error and stopped the injection.The continue button was pressed with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
The data files and electrophysiology (ep) catheter were returned and analyzed.The data files showed nine inj ections were performed with electrophysiology (ep) catheter 227f3 with lot number 63858-15 without any system notice.Additionally, the data files showed eleven injections were performed with electrophysiology (ep) catheter 227f3 with lot number 63858-24 without any system notice.The data files also showed that the following system notices 50005 (the safety system has detected fluid in the catheter and stopped the injection), and 50008 (the system has detected a software error and stopped the injection) appeared multiple times.Visual inspection of electrophysiology (ep) catheter 227f3 with lot number 63858 showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was not used.The catheter failed the performance test due to system notice 50005.Dissection test showed the blood inside the catheter handle.Pressure test showed a leakage at the tip of the catheter.In conclusion, the reported system notice 50005 was confirmed through data analysis and product analysis.The reported system notice 50008 was confirmed through data analysis but not through product analysis.The reported issue of visible blood could not be confirmed through data analysis, but was confirmed through product analysis.The root cause of the malfunction could not be confirmed through data analysis.The electrophysiology (ep) catheter failed the returned product inspection due to the leakage at the tip of the catheter.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE
• 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: 7874669
• Report Number: 3002648230-2018-00651
• Device Sequence Number: 227860
• Product Code: LPB
• UDI-Device Identifier: 00643169672475
• UDI-Public: 00643169672475
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2020
• Device Model Number: 227F3
• Device Catalogue Number: 227F3
• Device Lot Number: 63858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1