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

Model Number 106A3

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the screen on the console was frozen.The console was rebooted several times, but the issue persisted.Upon start up, a "no input detected" message was received.The power source was switched from a shared outlet to a dedicated outlet, and the message resolved.It was then reported that temperatures were bouncing around unexpectedly.The auto connection box was replaced, but the issue persisted.Once the catheter was connected , a system notice was received indicating that the safety system detected a compromised outer vacuum.Following the replacement of the electrical umbilical cable and balloon catheter, the console would not pass the system integrity test.The coaxial umbilical cable was also replaced but the screen continued to freeze upon reboot attempts and began to black out intermittently.Despite reboot attempts with the consumables being both connected and disconnected, the issues persisted.Occlusion of the left superior pulmonary vein (lspv) was achieved; however, due to the persisting issues, the case was ultimately aborted while the patient was under general anesthesia. no further patient complications have been reported as a result of this event.

• Brand Name: CRYOCONSOLE
• Type of Device: 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: 15525650
• MDR Text Key: 300997342
• Report Number: 3002648230-2022-00375
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00643169449596
• UDI-Public: 00643169449596
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 106A3
• Device Catalogue Number: 106A3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male