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

Model Number 106A3

Device Problems Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files did not show any attempted injections on the day of the event.The data files confirmed system notice #50024 and #11200 on the date of the event.In conclusion, the system notice of 50024, indicating that there was a problem with the refrigerant port, and the system notice of 11200, indicating that there is a problem with the system, 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 Description

It was reported that during a cryo ablation procedure, a system notice was received indicating that there was a problem with the refrigerant port.The console was also letting out a "hissing noise".The console was rebooted, coaxial port checked, and scavenging line reconnected multiple times and the notice could not be cleared.Then, a system notice was received indicating that there is a problem with the system.The case was aborted while the patient was under general anesthesia.A service visit took place at a later date and the "watchdog board" was replaced which resolved the issues.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the m731204b001 watchdog board with lot 06140159 from console n-6980 was returned for analysis.Visual inspection showed that the board was intact with no apparent issues.When assembled to the gen v console and following a warm up time of 30 minutes, the console along with an electrophysiology (ep) catheter and balloon test catheter passed the mechanical performance test.In conclusion, the watchdog board passed the performance as per specification.If the malfunction were to re-occur, it is not likely to cause or contribute to a death or serious injury.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.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 CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 10602146
• MDR Text Key: 209153250
• Report Number: 3002648230-2020-00518
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00643169449596
• UDI-Public: 00643169449596
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• 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: 09/08/2020
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR