MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION 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	12/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the console, 106a3 with serial number (b)(4), and field service report (fsr) were returned and analyzed.Bin files analysis showed a patient file was created for the date of event.Patient file showed 5 applications were performed.The bin files also showed an unrelated system notice 50028 (there is a problem with the injection process) at application 5 during thawing (58 sec from thawing start).Visual inspection of the console showed the console was intact without any issues.The console was connected to electrical power outlet and to vacuum hose (scavenging).Prior to turning the console on, the injection panel was inspected.The knob of the low-pressure regulator (lpr) and the high-pressure regulator (hpr) were setscrew locked.The injection panel was pressurized.Both the high-pressure gauge (hpg) and low-pressure gauge (lpg) showed 0 pounds per square inch (psi).When pressurized, lpg showed that the pressure is not constant, and was increasing from 0 to 349.85 psi and hpg was constant at 790 psi.The console along with balloon test catheter failed the performance test due to system notice 50028 (there is a problem with the injection process) earlier during inflation.The check valve cv7 has opened due to pressure higher than cracking pressure.The second inflation failed due to system notice 22406 (the balloon is deflated) earlier during inflation.The reading of lpg decreased from 349.85 to 128.42 psi.Third and fourth inflation attempts were sustained, but the console failed randomly due to system notice 50028 during ablation.The issue was isolated to intermittent wire connection between solenoid valve (s7) 12002-324 and the main harness.The connector of s7 was replaced to resume the analysis.The console failed performance test late during ablation due to system notice 50028.Probing across s7 showed the valve is not responding to drive control signal as expected.The valve failed open when is requested to close.Reboot of the console failed due to persistent power up test failure due to system notice 11200.On the bench, the voltage required to open and close s7 is higher than specified.Optical investigation of s7 revealed presence of debris particle (metallic) on the flange and scratches on the sleeve assembly.Interference is noticed between the plunger and the sleeve assembly.S7 was replaced and the console passed performance test.13 applications were performed without any issue.On cooling performance test, the console reached the required pressure of 500 ± 5 psi in a controlled way and within the requested time.No pressure overshoot was observed.When the preset pressure is set to 750 psi the pressure reached the required pressure (750 psi) in a controlled way and within the requested time without any issue.As per field service engineer report, the console was powered up multiple times with startup failures.Patient board and patient cable were replaced without resolution.The watchdog board and valve board were also replaced without resolution.Voltages were checked at motherboard and patient board with both being within tolerance.Solenoid valve 3 was checked electrically and physically to verify its function during the bt test.Valve was functioning properly.Pressure transducer 5 was also checked to verify its functionality in regard to the prs test.When pressure transducer 5 was reconnected, the console was shorted and powered off.When disconnected, the console would turn back on.This occurred 3 times before console began functioning normally.Additionally, per a second field service engineer report, the console was powered on without any startup errors.All console voltages were all within tolerance.Pressure transducer 5 functioned normally, and console would not short when disconnected and reconnected.Console was repeatedly rebooted to try to reproduce the startup errors.Startup tests all passed.Console system self-tests on the prs, lkt and bt all pass as well.Prs, lkt and bt functionality were also verified using balloon catheter simulator.During final testing pressure transducer 5 crept slowly into tolerance.500028 system notice appeared when trying to enable vacuum.The console was rebooted and original start up error appeared.Analog board and pressure transducer 5 were swapped out to resolve issue.Startup error persisted with same errors (lkt, prs, bt).Additionally, per a third field service engineer report, the console was powered on and verified startup error.Replaced pressure transducer 5.Reboots were done without any errors.Prs, lkt, bt tests were done with balloon simulator.Pressure transducer 5 atmospheric pressure was fluctuating, and 50028 system notices appeared when enabling vacuum reboot was done with start-up errors appearing once more.Watchdog board and analog board were also replaced a second time without any success in regard to the start-up errors.Connected pressure transducer 5 and pressure transducer 6 directly together to see if pressure transducer 5 reads an appropriate value.In conclusion, the reported issue (system notice 50028 and 11200) has been confirmed through testing and through data analysis.The console 5m0453 failed the performance test during inflation due to system notices 50028 and 22406.The console triggered system notice 50028 due to low pressure regulator leak.The console failed performance test during ablation due to persistent system notice 50028 due to intermittent wire connection between solenoid valve (s7 and the main harness and solenoid valve (s7) 12002-324 failure due to presence of debris and interference between the plunger and the sleeve.The reported issue, system notice 21200 (system self-test did not pass), has not been confirmed through testing.The product issues reported 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.
Event or Problem Description
It was reported that during a cryo ablation procedure, a system notice was received indicating that the system self-test did not pass.The console was rebooted multiple times without resolve.The scavenging and vacuum lines were disconnected and reconnected without resolve.The case outcome is unknown.A field service visit was recommended.No patient complications have been reported as a result of this event.Incoming information indicated that the console was uninstalled and replaced.Additional information indicated the case was aborted while the patient was under general anesthesia.Incoming information indicated field service took place to no avail.

• Brand Name: CRYOCONSOLE
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7307803
• Report Number: 3007566237-2018-00618
• Device Sequence Number: 13719916
• Product Code: LPB
• UDI-Device Identifier: 00643169946644
• UDI-Public: 00643169946644
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 03/01/2018
• 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