MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD 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	03/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The data files were returned and analyzed.The data files confirmed that system notice 50012 ¿the refrigerant delivery path is obstructed¿ was observed with multiple balloon catheters on the date of the event.The product issue reported system notice 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.The physical product was not returned for analysis.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 refrigerant delivery path was obstructed.The coaxial umbilical cable was reconnected without resolve.The tank, vacuum and airway were checked.The coaxial umbilical cable, electrical umbilical cable, and auto connection box were replaced without resolve.The console was rebooted, the gas was vented, and the tank replaced, without resolve.The balloon catheter was then replaced without resolve.The procedure was aborted with the patient under general anesthesia.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): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• MDR Report Key: 8525002
• Report Number: 3004593495-2019-00350
• Device Sequence Number: 14152713
• Product Code: LPB
• UDI-Device Identifier: 00643169946644
• UDI-Public: 00643169946644
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 04/17/2019

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: 03/26/2019
• Initial Report FDA Received Date: 04/17/2019
• 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
• Patient Age: 71 YR