MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP 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 12/11/2019

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, a system notice was received indicating that there is a problem with the system.The console was rebooted four times with the same system notice.The scavenging hose was disconnected from the console and the system was rebooted.However, the system notice was still persistent and then a system notice was received indicating that there was a problem with the refrigerant port.Additionally, pressure/flow issues were observed during the case.The case was aborted and the patient was under general anesthesia.A field service visit was recommended as a result of this event.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the universal valve board 11000-s131-01 and universal watchdog board m731200b001 were returned and analyzed.Visual inspection showed that the valve board was intact with no apparent issues.It was assembled to a test console and following a warm up time of 30 minutes, the console, with a test balloon catheter, passed the performance test as per specification.Visual inspection of the watchdog board showed that the board was intact with no apparent issues.It was assembled to a test rohs console with the original cpu and usb drives and following a warm up time of 30 minutes, the console, with a test balloon catheter and passed the functional test.In conclusion, the valve board and watchdog board did not fail the returned product inspection due to the system notices and flow issues.Additionally, if the reported 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files confirmed system notice 50024 ¿there is a problem with the refrigerant port¿ several times for the date of the event.Additionally, power up code 11200 was triggered on the date of the event.The product issues reported of system indicating that there is a problem with the system and system notice indicating that there was a problem with the refrigerant port 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 CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 9551243
• MDR Text Key: 185373216
• Report Number: 3002648230-2020-00009
• 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,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• 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: 01/28/2020
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other