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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the injection proportional valve and valve board from the 106a3 console (b)(4) were returned and analyzed.During external visual inspection of the injection proportional valve it was observed that the returned part was intact with no apparent issues.The injection proportional valve was assembled to the test console following a warm-up time of 30 minutes, the console along with the test catheter failed the performance test due to the system notice 12221 "the system detected a high level of refrigerant flow during the system flush, and the system flush was stopped." further analysis through the cooling performance test showed that the injection pressure at pressure transducer 1 was not as expected and it was noted that the injection pressure value was not responding to proportional¿integral¿derivative control when the requested injection pressure was varied.During external visual inspection of the valve board, it was observed that the returned part was intact with no apparent issues.The valve board was assembled to the test console following a warm-up time of 30 minutes.The console along with the test catheter passed the performance test without any issues.The console passed multiple power test with no issues.In conclusion, the physical console was not returned, the injection proportional valve and valve board on the console were replaced in the field during servicing, the returned injection proportional valve was tested and confirmed defective, and the valve board was tested and confirmed functional.The product issue reported (system notice 50030) 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 a high level of refrigerant flow and stopped the injection.The console was restarted, the balloon catheter, electrical umbilical cable, coaxial umbilical cable and auto connection box were replaced which did not resolve the issue. the case was aborted and the patient was under general anesthesia.Service was performed at a later date.  the injection proportional valve (mks) and the valve board were replaced which resolved the issue.The console was serviced as appropriate.No 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
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14977809
• Report Number: 3002648230-2022-00271
• Device Sequence Number: 5035150
• Product Code: LPB
• UDI-Device Identifier: 00613994775955
• UDI-Public: 00613994775955
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2022

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 Model Number: 106A3
• Device Catalogue Number: 106A3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown