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

Model Number 106A3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed ten applications were performed with balloon catheter 2af284 with lot number 09527.The data files indicated system notice 50002, was received indicating that the system detected an electrical component failure.Additionally, the files indicated system notice 50032, was also received indicating that the safety system detected a compromised outer vacuum.These system notices were received in a range of multiple applications.Short inflations were also observed.In conclusion, the reported 12218 system notice, indicating that the safety system detected a compromised outer vacuum, 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.There is no indication of relation of adverse event to the performance of the cryo device.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, immediately following the system integrity test, a system notice was received indicating that the safety system detected a compromised outer vacuum.The electrical umbilical cable was replaced twice without resolve, and the auto connection box and balloon catheter were also replaced without resolve.Test injections were performed, demonstration disposables used, and the auto connection box bypassed, but the system notice indicating that the safety system detected a compromised outer vacuum was reproduced.After applying light pressure to the electrical umbilical cable coaxial port on the console, a system notice was received indicating that the safety system detected a compromised outer vacuum.The procedure was aborted, and the patient was under general anesthesia.A field service visit was recommended.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the console patient board and patient cable were returned and analyzed.Visual inspection showed that the board was intact with no apparent issues.It was assembled to the console with the original cpu and usb drives and following a warm up time of 30 minutes, the console was tested along with a test balloon catheter and passed the functional test.Visual inspection of the cable showed that two of the autoconnection box connector wires were broken and probably was causing the issue.These product issues 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
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8416707
• MDR Text Key: 138666899
• Report Number: 3007566237-2019-00601
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00763000011147
• UDI-Public: 00763000011147
• Combination Product (y/n): N
• PMA/PMN Number: P020045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other